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  • Dispositivo 9
  • Fabricante 6
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2482-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100518
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2483-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100520
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2484-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100521
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2485-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100522
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Alerta De Seguridad para Coronary Angioplasty Guide, model: Galeo.
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2486-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100524
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2487-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100525
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2488-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100526
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2489-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100528
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Alerta De Seguridad para Coronary Angioplasty Guide, model: Galeo.
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2490-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100529
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2491-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100530
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2492-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100531
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2493-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100533
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Alerta De Seguridad para Galeo M 014 and F014
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2494-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100534
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2495-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100535
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2496-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100537
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2497-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100540
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Alerta De Seguridad para Galeo
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2498-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100541
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2499-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100542
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2500-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100543
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Retiro De Equipo (Recall) de Device Recall Innova SelfExpanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    58910
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2501-2011
  • Fecha de inicio del evento
    2011-05-19
  • Fecha de publicación del evento
    2011-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100545
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, superficial femoral artery - Product Code NIP
  • Causa
    Boston scientific corporation is conducting a recall of the innova self-expanding stent system because they have received 6 complaints involving no deployment/partial deployment of the innova stent. potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. this recall d.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.
Alerta De Seguridad para Coronary Spirals Taxus or Stents
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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