Medtronic Neuromodulation
64 recalls on record · Latest: Jan 21, 2026
FDA Devices Moderate Jan 21, 2026
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on S…
FDA Devices Moderate Dec 31, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900…
FDA Devices Moderate May 7, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Devices Moderate Apr 16, 2025
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimul…
FDA Devices Moderate Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2…
FDA Devices Moderate Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, …
FDA Devices Moderate Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
FDA Devices Moderate Oct 30, 2024
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
FDA Devices Moderate Sep 18, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM…
FDA Devices Moderate Jan 3, 2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
FDA Devices Moderate Jan 3, 2024
Medtronic SynchroMed II, Model 8637-40, Programmable pump
FDA Devices Moderate Nov 8, 2023
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
FDA Devices Moderate Oct 25, 2023
SenSight Connector Plug, Model Number B31061.
FDA Devices Moderate Oct 11, 2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
FDA Devices Moderate Aug 16, 2023
Medtronic InterStim Ground Pad REF 041826
FDA Devices Moderate Aug 2, 2023
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
FDA Devices Moderate Jul 5, 2023
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
FDA Devices Moderate Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
FDA Devices Moderate Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
FDA Devices Moderate Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
FDA Devices Moderate Jan 18, 2023
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
FDA Devices Moderate Aug 31, 2022
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain ther…
FDA Devices Moderate Jun 1, 2022
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part o…
FDA Devices Moderate Jun 1, 2022
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
FDA Devices Moderate Jun 1, 2022
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
FDA Devices Moderate May 4, 2022
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) T…
FDA Devices Moderate Dec 1, 2021
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), R…
FDA Devices Moderate Dec 1, 2021
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
FDA Devices Moderate Aug 18, 2021
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
FDA Devices Moderate Aug 4, 2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
FDA Devices Moderate May 12, 2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveSti…
FDA Devices Moderate Jan 20, 2021
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by cli…
FDA Devices Moderate Dec 23, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is i…
FDA Devices Critical Dec 11, 2019
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
FDA Devices Moderate Jul 25, 2018
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kit…
FDA Devices Moderate Jul 25, 2018
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A…
FDA Devices Moderate Mar 14, 2018
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed…
FDA Devices Low Feb 14, 2018
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 0…
FDA Devices Moderate Aug 30, 2017
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit conta…
FDA Devices Critical Mar 8, 2017
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician…
FDA Devices Moderate Aug 31, 2016
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
FDA Devices Moderate Aug 31, 2016
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neuro…
FDA Devices Moderate Jun 15, 2016
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intrac…
FDA Devices Moderate Apr 6, 2016
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
FDA Devices Moderate Mar 2, 2016
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating ch…
FDA Devices Moderate May 27, 2015
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
FDA Devices Moderate Mar 4, 2015
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, …
FDA Devices Moderate Aug 20, 2014
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda…
FDA Devices Moderate Jun 11, 2014
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system…
FDA Devices Moderate May 14, 2014