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Medtronic Neuromodulation FDA Recalls
50 recalls on file across devices, 0 of them Class I and 48 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsClass IIMay 13, 2026A limited number of Pocket Adaptor Kits, Model 64001 and 640 |
| Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsClass IIMay 13, 2026A limited number of Pocket Adaptor Kits, Model 64001 and 640 |
| Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following deviceClass IIApr 8, 2026Software issue: When programming the SynchroMed Pump with t |
| A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software Class IIDec 3, 2025Complaints received that Vanta A71200 CP App does not functi |
| Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90Class IINov 20, 2025Software issue where a Device Reset message displayed on the |
| Enhanced Verify Evaluation Handset (CFN HH90130FA)Class IIApr 3, 2025Evaluation handsets may not be able to communicate with the |
| Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis PClass IIMar 4, 2025There is a software issue that can permanently disable commu |
| A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.Class IIJan 9, 2025Product complaints were received describing the A820 myPTM a |
| SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with Class IINov 21, 2024Software issues were identified in application version 2.x. |
| SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK wClass IINov 21, 2024Software issues were identified in application version 2.x. |
| SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSClass IINov 21, 2024Software issues were identified in application version 2.x. |
| SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL wClass IINov 21, 2024Software issues were identified in application version 2.x. |
| Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.Class IISep 24, 2024A limited number of Percept RC Implantable Neurostimulators |
| Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeaClass IISep 18, 2024The Wireless Rechargers in the kits may be unable to enter a |
| SynchroMed II Infusion Pump. Product Number: 8637-20Class IISep 11, 2024Potential for error and inability to interrogate pump due to |
| Vanta Implantable Neurostimulator (INS), Model 977006Class IIAug 21, 2024Model 977006 Vanta INS batterty life has depleted faster tha |
| Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the MoClass IIJun 17, 2024A subset of the handsets within the kit may not be able to c |
| A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594Class IIMay 15, 2024Patients implanted with a pocket adaptor (Model 64001 and/or |
| Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisiClass IIMay 10, 2024Design update to the Ascenda Intrathecal Catheter Models 87 |
| Intellis AdaptiveStim Product Number 97715, Spinal Cord StimulatorClass IIMar 28, 2024inability to reprogram one device |
| Model A710 Intellis Clinician Programmer Application, version 2.0.97Class IIDec 19, 2023Medtronic has discovered an instance in which the Intellis A |
| Medtronic SynchroMed II, Model 8637-40, Programmable pumpClass IINov 13, 2023Medtronic recently identified that if the SynchroMed II pump |
| Medtronic SynchroMed II, Model 8637-20, Programmable pumpClass IINov 13, 2023Medtronic recently identified that if the SynchroMed II pump |
| Model 97745 Controller used with Models 97715 and 97716 Intellis NeurostimulatorsClass IIOct 19, 2023Units distributed in Korea and Turkey that did not have the |
| Medtronic InterStim Ground Pad REF 041826Class IIJul 6, 2023Lot of InterStim Self-Adhesive Ground Pad is being recalled |
| A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..Class IIJun 21, 2023When an update to the A710 Clinician Programmer software app |
| Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulationClass IIJun 6, 2023A cardioversion procedure may damage the electronics in the |
| Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling andClass IIMar 17, 2023Medtronic has received reports of SenSight Extension Tunnele |
| SenSight Connector Plug, Model Number B31061.Class IIJan 20, 2023Medtronic is requesting return of a small number of units of |
| Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900CClass IIDec 3, 2022Software anomalies, CP App messages: "Too Many Device Found |
| Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900BClass IIDec 3, 2022Software anomalies, CP App messages: "Too Many Device Found |
| Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900DClass IIDec 3, 2022Software anomalies, CP App messages: "Too Many Device Found |
| Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900EClass IIDec 3, 2022Software anomalies, CP App messages: "Too Many Device Found |
| Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900AClass IIDec 3, 2022Software anomalies, CP App messages: "Too Many Device Found |
| Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable nClass IIJul 26, 2022Potential for Vanta Clinician Programmer Application (CP App |
| Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable nClass IIJul 26, 2022Potential communication issue in which the Vanta Clinician P |
| LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.Class IIMay 27, 2022There are a small number of units of the DBS Lead with StimL |
| Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200Class IIMar 30, 2022The Implantable Neurostimulator (INS) cannot communicate wit |
| Percept BrainSense Implantable Neurostimulator (INS), Model B35200Class IIMar 30, 2022The Implantable Neurostimulator (INS) cannot communicate wit |
| Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with SuClass IIMar 30, 2022The Implantable Neurostimulator Model may be susceptible to |
| MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, ModClass IIFeb 28, 2022There is a software anomaly with the InterStim X Clinician s |
| Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810)Class IINov 4, 2021The wireless rechargers (WR; WR9200 and WR9220; included in |
| Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RClass IINov 4, 2021The wireless rechargers (WR; WR9200 and WR9220; included in |
| Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implaClass IINov 4, 2021The wireless rechargers (WR; WR9200 and WR9220; included in |
| Model B35200 - Percept PC BrainSense Implantable NeurostimulatorClass IIOct 19, 2021During cardioversion events, the Model B35200 Percept PC Imp |
| Clinician Programmer Application (CPA) model A610 Clinician Software ApplicationClass IISep 23, 2021A software anomaly may occur with the clinician programmer a |
| Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290Class IIJul 9, 2021Specific PINs of the Vectris SureScan MRI lead kits contain |
| Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 gClass IIJun 2, 2021Excess nylon flash on the clip. |
| Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulatorsClass IIMar 25, 2021There is a potential for unintended heating that can occur w |
| A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 NeuClass IIMar 9, 2021There are two issues within this correction action: 1. Cycl |