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  • Dispositivo 12
  • Fabricante 10
  • Evento 124969
  • Implante 5
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1104-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28358
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1105-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28362
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1106-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28369
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1107-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28370
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1108-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28371
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1109-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28372
  • 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
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1110-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28374
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1111-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28375
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1112-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28376
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1113-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28377
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1114-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28378
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1115-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28380
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1116-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28381
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1117-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28382
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1118-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28383
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1119-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28384
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
  • Tipo de evento
    Recall
  • ID del evento
    26708
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1120-03
  • Fecha de inicio del evento
    2003-07-01
  • Fecha de publicación del evento
    2003-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28385
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code GBR
  • Causa
    Some of the product pouches have holes in the seals.
  • Acción
    Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Retiro De Equipo (Recall) de Device Recall DatexOhmeda
  • Tipo de evento
    Recall
  • ID del evento
    26765
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0937-03
  • Fecha de inicio del evento
    2003-07-15
  • Fecha de publicación del evento
    2003-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28387
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • Causa
    Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
  • Acción
    Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.
Retiro De Equipo (Recall) de Device Recall Baxter
  • Tipo de evento
    Recall
  • ID del evento
    26772
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1150-03
  • Fecha de inicio del evento
    2003-07-16
  • Fecha de publicación del evento
    2003-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28397
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Causa
    There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
  • Acción
    Recalled by letter dated 7/16/03. The accounts were informed of the potential for leaks in the set tubing, and asked to inspect their inventory for the affected product codes and lots, segregate any affected products found and discard them according to local procedures. The customers will receive credit for the discarded affected product.
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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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La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

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