FDA Device Recalls

Recalls / Firms / Medtronic Neuromodulation

Medtronic Neuromodulation

173 FDA device recalls on record.

DateClassProductReason
2025-12-03A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product numbe
2025-11-20Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:
2025-04-03Enhanced Verify Evaluation Handset (CFN HH90130FA)
2025-03-04Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 97
2025-01-09A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
2024-11-21SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINI
2024-11-21SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINI
2024-11-21SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINI
2024-11-21SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINI
2024-09-24Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
2024-09-18Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Rec
2024-09-11SynchroMed II Infusion Pump. Product Number: 8637-20
2024-08-21Vanta Implantable Neurostimulator (INS), Model 977006
2024-06-17Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kit
2024-05-15A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x
2024-05-10Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (cat
2024-03-28Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
2023-12-19Model A710 Intellis Clinician Programmer Application, version 2.0.97
2023-11-13Medtronic SynchroMed II, Model 8637-20, Programmable pump
2023-11-13Medtronic SynchroMed II, Model 8637-40, Programmable pump
2023-10-19Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
2023-07-06Medtronic InterStim Ground Pad REF 041826
2023-06-21A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer appli
2023-06-06Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
2023-03-17Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist
2023-01-20SenSight Connector Plug, Model Number B31061.
2022-12-03Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model
2022-12-03Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model
2022-12-03Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model
2022-12-03Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model
2022-12-03Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model
2022-07-26Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006
2022-07-26Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006
2022-05-27LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
2022-03-30Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neu
2022-03-30Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
2022-03-30Percept BrainSense Implantable Neurostimulator (INS), Model B35200
2022-02-28MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset wi
2021-11-04Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC
2021-11-04Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUl
2021-11-04Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim
2021-10-19Model B35200 - Percept PC BrainSense Implantable Neurostimulator
2021-09-23Clinician Programmer Application (CPA) model A610 Clinician Software Application
2021-07-09Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
2021-06-02Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e)
2021-03-25Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargea
2021-03-09A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept
2020-11-19Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation d
2020-11-12Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application versio
2020-07-17Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neuro
2019-10-11Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
2019-05-15InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The
2018-05-25Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (
2018-05-25Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 P
2017-09-21Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b
2017-08-09Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Produc
2017-03-17DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S
2017-02-09SynchroMed II implantable drug infusion pump, Model 8637-40,
2016-10-03Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to ch
2016-10-03Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Softwar
2016-06-23DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) P
2016-06-10Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 338
2016-05-03Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable N
2016-02-09Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
2016-01-11Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads.
2015-04-16Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
2015-04-10Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product U
2015-01-09The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use i
2014-07-14Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only
2014-07-11Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump S
2014-06-11Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction wit
2014-05-02Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Int
2014-04-04Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Progra
2014-02-27Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (
2014-02-27Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimul
2014-02-27Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (
2014-02-26Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Med
2013-09-30Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimul
2013-09-30Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Mu
2013-09-30Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neur
2013-09-30Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neur
2013-06-03Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length mar
2013-06-03Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length marking
2013-06-03Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pump
2013-06-03Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with at
2013-06-03Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segme
2013-06-03Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir
2013-06-03Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir
2013-06-03Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pump
2013-02-27Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of s
2013-02-08Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. St
2013-02-08Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogeni
2012-12-03Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manu
2012-11-09Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir
2012-11-09SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. i
2012-03-12Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System.
2009-10-27Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of th
2009-08-27Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. M
2009-08-27Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Et
2009-08-27Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. Medtronic,
2009-08-27Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxi
2009-08-25Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra T
2009-07-01Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtroni
2009-03-23Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer.
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The contents [STERILE]
2008-08-25Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE]
2008-06-26Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length markers and guide
2008-06-26Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: Catheter interface with at
2008-06-26Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with length markers and gu
2008-06-26Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm pump segme
2008-06-14Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner
2008-06-14Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, M
2008-06-14Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 12.0 mm,
2008-06-14Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner
2008-06-05PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System
2008-05-21Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc
2008-05-12Medtronic Patient programmer, model 37742. The Patient programmer is a hand held, battery operated,
2008-05-12Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery opera
2008-05-01Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 20 ml Pumps M
2008-05-01Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40 ml Pumps M
2008-04-25Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic P
2008-04-14Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II
2008-04-14Medtronic 8578 Sutureless Pump Connector Revision Kit Medtronic Inc., Minneapolis, MN 55432 A part
2008-04-14Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part
2008-04-14Model 8596SC Intrathecal Catheter Pump Segment Revision Kit Medtronic Inc., Minneapolis, MN 55432 A
2008-03-01Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the in
2008-02-04IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMe
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-18. The contents of the inner packag
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner packag
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner packag
2008-01-16Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner
2008-01-16Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-20. The contents of the inner
2008-01-16Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have be
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8626-18. The contents of the inner package
2008-01-16Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inn
2008-01-16Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package
2008-01-16Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner packag
2008-01-16Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have be
2008-01-09Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Mode
2007-12-03Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and
2007-10-01Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic
2007-10-01Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, R
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8626-18. Medtronic, Inc., 710 Medtronic Parkway, M
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8626-10. Medtronic, Inc., 710 Medtronic Parkway, M
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8626L-18, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic Parkway, Mi
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8627-18. Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710 Medtronic Parkway,
2007-08-03Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic Parkway, M
2007-08-03Medtronic SynchroMed EL Programmable Pumps, Model 8627-10, Medtronic, Inc., 710 Medtronic Parkway, M
2007-06-25Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870
2007-06-25Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870
2007-04-16Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5
2007-04-06Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S Tonsbakken
2006-06-06Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implan