The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Modification of the meters / obturators and the AOEi measuring frame of the Mosaic ™ porcine aortic bioprosthesis model 305, manufactured by Medtronic Inc, United States, due to the possibility of overmetering or implanting a larger valve than
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of all lots and models of the Select 3D ™ and Select CAP ™ arterial cannula families, manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain batches of the product "Model 8551 filling kit used with Synchromed implantable infusion pumps", manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of the Nexdrive® micropositioning system, models MI-1000 and MI-2000, manufactured by Medtronic Inc, USA, due to the possible incorrect alignment of the Z axis of coordinates.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Removal from the market of certain batches of the Nexdrive® micropositioning system, models MI-1000 and MI-2000, manufactured by Medtronic Inc, USA, due to the possible incorrect alignment of the Z axis of coordinates.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possible problem of functioning of the bicameral external pacemaker, model 5392, with serial number equal to or lower than DJH009999P, manufactured by Medtronic Inc, United States, when certain batteries of size AA (LR6) are used.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Recommendations for the follow-up of patients carrying certain pacemakers TRC-P InSync® III, manufactured by Medtronic Inc, USA, due to the possibility of an insufficient supply of electric current to the battery.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possibility that the RRT alert (recommended replacement time) is activated prematurely in the Reveal LINQ insertable heart monitors, manufactured by Medtronic Inc, USA, resulting in the deactivation of alerts and wireless daily communications after 30 days.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Software update on Reveal LINQ insertable cardiac monitors, manufactured by Medtronic Inc, USA, due to the possibility that the RRT alert (recommended replacement time) is activated prematurely and alerts and communications are deactivated wireless day after 30 days.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possible premature battery depletion of certain implantable cardioverter defibrillators (CRT-D) Viva ™ and Evera ™ implantable automatic defibrillators (ICDs), manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Update of the Model 8870 software card used in the N'VisionTM 8840 Medical Programmer and the instructions for use of the SynchroMed® II Implantable Infusion Systems, manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Information on the software update of the 2090 programmer that will detect the possible erroneous activation of the ERI / RRT (Elective Replacement Indicator) in certain dual chamber pacemakers, manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possible appearance on the screen of the N'Vision medical programmer, manufactured by Medtronic Inc., of an incorrect replacement date for SynchroMed® II pumps that may result in the pump reaching the end of its life before replacement .
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain "Deep Brain Stimulation Extension Equipment", manufactured by Medtronic Inc., USA, because they may contain a damaged radiopaque finned connector sheath
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possibility that the electrode for deep brain stimulation (DBS), manufactured by Medtronic Inc. (USA), is damaged at its connection end due to the use of the cap.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Possibility of certain problems with the Synchromed II® and Synchromed EL implantable pumps, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of certain Consult® CRT-P and Syncra® CRT-P devices, number of models C2TR01 and C3TR01, manufactured by Medtronic Inc., USA, due to the possibility of leakage of the seal
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal from the market of DBS ™ electrode kits, models 3387, 3387S, 3389, 3389S, 3391, 3391S, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notes supplémentaires dans les données
Action
Withdrawal of intrathecal catheters with sutureless connector, models 8709SC, 8731SC, 8596SC, 8578, with an expiration date prior to August 25, 2014, manufactured by Medtronic Inc., USA, due to an increased risk of occlusion.