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  • Dispositivo 14
  • Fabricante 10
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0976-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45671
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0977-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45672
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0978-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45673
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0979-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45674
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Cook Esophageal Dilator Set --------------------------------------Sm...
  • Tipo de evento
    Recall
  • ID del evento
    35265
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0848-06
  • Fecha de inicio del evento
    2006-04-20
  • Fecha de publicación del evento
    2006-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45689
  • 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 KOG
  • Causa
    Large product label contains an incorrect expiration date.
  • Acción
    Consignees were notified by letter (USPS certified)on/about April 21, 2006.
Retiro De Equipo (Recall) de TriActiv ProGuard Embolic Protection System
  • Tipo de evento
    Recall
  • ID del evento
    35280
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1305-06
  • Fecha de inicio del evento
    2006-04-06
  • Fecha de publicación del evento
    2006-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45714
  • 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
    Embolic Protection System - Product Code NFA
  • Causa
    Alarm activiation-a priming issue involving the flow control unit due to a software problem has caused false postive extraction line block (elb) alarming. use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.
  • Acción
    The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
Retiro De Equipo (Recall) de Electrosurgical, cutting & coagulation & accessories.
  • Tipo de evento
    Recall
  • ID del evento
    35283
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0859-06
  • Fecha de inicio del evento
    2006-04-21
  • Fecha de publicación del evento
    2006-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45717
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    Electrosurgical ablation device may experience loss of power during use, when used with cool-tip switching controller in ablation mode.
  • Acción
    Consignees were notified by telephone followed by a fax on 04/21/2006.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1089-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45730
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the plastic tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1090-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45731
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the plastic tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1091-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45732
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the plastic tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1092-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45733
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the plastic tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de St. Jude Medical AGILIS Steerable Catheter Introducer
  • Tipo de evento
    Recall
  • ID del evento
    35300
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1086-06
  • Fecha de inicio del evento
    2006-04-14
  • Fecha de publicación del evento
    2006-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-04-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45749
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    St jude medical has determined that a limited number of agilis steerable introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. the risks that exist are related to the loss of hemostasis through the agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.
  • Acción
    A Field Action Notification, dated 04/13/06, was sent to hospital's Electrophysiology labs (cath labs) and to physicians. This Notification describes the issue, the risk to patient, identifies lot numbers of product affected and states that a SJM Rep will be contacting them soon. The SJM Reps visited the hospitals to verify they received the notification and retrieve affected product. Replacement product will be provided at no charge. EXPANDED RECALL A Field Action Notification, dated 06/01/06, was sent to hospital's Electrophysiology labs (cath labs) and to the physicians who reported a problem with the device. This Notification describes the issue, risk to patients, identifies lot numbers and states that a SJM Representative will be contacting them soon to facilitate the return of product. Replacement product will be offered at no charge. The physician notification, dated 06/01/2006, describes the issue, the risk, lot number affected and informs them that a notification has been sent to the hospitals EP Lab.
Retiro De Equipo (Recall) de Pivot
  • Tipo de evento
    Recall
  • ID del evento
    35301
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0895-06
  • Fecha de inicio del evento
    2006-04-26
  • Fecha de publicación del evento
    2006-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45757
  • 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
    Catheter, Continuous Flush - Product Code KRA
  • Causa
    During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.
  • Acción
    On 4/25/06, the firm initiated the recall notification via letters explaining the reason for the recall and requesting the product be returned.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1094-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45766
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de Aortic Perfusion Cannula
  • Tipo de evento
    Recall
  • ID del evento
    35291
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1095-06
  • Fecha de inicio del evento
    2006-04-18
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45768
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Due to potential embrittlement of the overmolded plastic portion of the metal tip which may crack or separate during use.
  • Acción
    Consignees were notified by letter and visit beginning 04/18/2006.
Retiro De Equipo (Recall) de Weck Hemolok ML Polymer Ligating Clips
  • Tipo de evento
    Recall
  • ID del evento
    35316
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1096-06
  • Fecha de inicio del evento
    2006-04-12
  • Fecha de publicación del evento
    2006-06-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45799
  • 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
    Polymer Ligating Clips - Product Code FZP
  • Causa
    The hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
  • Acción
    Teleflex Medical sent Important Product Safety Information letters dated 4/18/06 to all of their customers who have purchased Hem-o-lok Ligating Clips from Teleflex. The letters informed the healthcare providers that Teleflex has been made aware of incidents in which the ligating clips (sizes L and XL) were reported to have become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Although none of the incidents appear to have involved any defect in or malfunction of the ligating clips, misapplication of the Hem-o-lok clips during such laparascopic procedures may not immediately be apparent and can have serious, even life-threatening consequences post-operatively. Therefore, Teleflex has added the following contraindication to the Instructions for Use accompanying the Hem-o-lok Polymer Ligating Clips: 'Contraindications': Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic nephrectomies in living donor patients. 'Caution': The clip must be latched to ensure proper ligation of the vessel or tissue. Inspect the ligation site after application to ensure proper closure of the clip. Security of the closure should be confirmed after ligation. The Hem-o-lok Polymer Ligating Clip is not designed for use as a tissue marker. Weck recommends that more than one clip be used to ligate the renal artery in procedures other than laparoscopic donor nephrectomy (see Contraindication, above). Application of more than one clip to all other vessels should be left to the surgeon's judgment.' Any questions concerning the letter were directed to Teleflex Medical at 800-334-9751, option #7, then option #5. Teleflex sent follow-up ¿Important Product Correction Notice¿ letters dated 8/2/06 to all of their Hem-o-lok Ligating Clips customers via registered mail on 8/7/06. The letters provide clarification of the 4/18/06 letter, reinforcing that the clips are contraindicated for use in ligating t
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0980-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45802
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0981-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45804
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0982-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45805
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0983-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45806
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0984-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45807
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0985-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45808
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0986-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45809
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0987-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45810
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
Retiro De Equipo (Recall) de Medtronic
  • Tipo de evento
    Recall
  • ID del evento
    35236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0988-06
  • Fecha de inicio del evento
    2006-04-05
  • Fecha de publicación del evento
    2006-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45815
  • 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
    Catheter, Percutaneous - Product Code DQY
  • Causa
    Potential for non-sterility due to loss of package integrity.
  • Acción
    Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
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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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