Medtronic Neuromodulation recalls
Every recall we track for Medtronic Neuromodulation — 59 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Medtronic Neuromodulation fell by more than half in 2025 (5, down from 12 in 2024). 2% rated “stop using now”.
All FDA recall records for Medtronic Neuromodulation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 1 | 0 | 2 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 3 | 0 | 3 |
| 2021 | 1 | 1 | 7 | 0 | 9 |
| 2022 | 0 | 0 | 11 | 1 | 12 |
| 2023 | 0 | 2 | 7 | 0 | 9 |
| 2024 | 0 | 0 | 12 | 0 | 12 |
| 2025 | 0 | 2 | 3 | 0 | 5 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
Most common reasons for Medtronic Neuromodulation recalls
What to do if you have a recalled Medtronic Neuromodulation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic Neuromodulation recalls
46 shown- Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for
Medtronic recalls 1x4 Pocket Adaptor Kits for Deep Brain Stimulation with incorrect Use-By-Dates. Model 64001 and 64002 kits have specific lot numbers and GTINs listed in the recall.
MedtronicMay 13, 2026 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following
Medtronic recalls certain SynchroMed Flex Infusion Programmer software versions that may display infusion steps out of order, causing missed medication schedules. Affected devices include specific clinician tablets with model numbers CT900A through CT900F and software versions 1.x and 2.x.
MedtronicApr 8, 2026 - Lower riskMedical device
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software
Medtronic recalls specific versions of their Vanta Clinician Programmer software for Samsung tablets due to potential delays in surgical procedures. Affected users should contact Medtronic for details.
MedtronicDec 3, 2025 - Lower riskMedical device
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A
Medtronic recalls Restore Clinician Programmer App Model A71100 software versions before v.1.0.4489. Rare device reset issues may cause pain recurrence. Affected users should contact Medtronic for repair or replacement.
Medtronic NeuromodulationNov 20, 2025 - Use cautionMedical device
Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic recalls Enhanced Verify Evaluation Handsets (CFN HH90130FA) due to potential communication failure with neurostimulators, which may cause therapy interruption and return of symptoms like urinary retention or incontinence.
MedtronicApr 3, 2025 - Use cautionMedical device
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application Model A71400 when used with specific neurostimulators due to a software issue that can permanently disable communication with implantable neurostimulators during certain programming sequences.
Medtronic NeuromodulationMar 4, 2025 - Lower riskMedical device
Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic recalls A820 myPTM software for SynchroMed pumps due to delayed patient interactions with implantable pumps. Affected units have specific version and UDI/DI numbers.
Medtronic NeuromodulationJan 9, 2025 - Lower riskMedical device
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL
Medtronic recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps with specific software versions due to potential software issues. Affected units include certain serial numbers and GTINs.
MedtronicNov 21, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Medtronic recalls 12 specific model B35300 implantable neurostimulators that fail to communicate with the A610 Clinician Programmer, showing an 'Invalid Device' message. Affected units have unique serial numbers and GTINs listed in the recall.
MedtronicSep 24, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for
Medtronic recalls Recharger Kits RS6230, RS7230, and RS5220A that may fail to enter recharging session upon first use. Affected units include specific serial numbers and models for deep brain stimulation and pelvic health systems.
MedtronicSep 18, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls SynchroMed II Infusion Pump. Product Number: 8637-20
Medtronic recalls SynchroMed II Infusion Pumps (Product 8637-20) due to potential data corruption causing pump errors and inability to check settings. Affected units have specific serial numbers.
Medtronic NeuromodulationSep 11, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Vanta Implantable Neurostimulator (INS), Model 977006
Medtronic recalls Vanta Implantable Neurostimulator (INS) Model 977006 due to shorter battery life than expected, potentially requiring earlier outpatient reprogramming or surgical replacements than planned.
Medtronic NeuromodulationAug 21, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the
Medtronic recalls specific Handset with Communicator models TH90Q01 that may fail to pair with communicator during initial setup. Affected units have serial numbers listed in the recall notice.
MedtronicJun 17, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584,
Medtronic Neuromodulation
MedtronicMay 15, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Medtronic recalls specific models of Ascenda Intrathecal Catheters (8780, 8781, 8784) due to a design update that may lead to tissue growth in the catheter connector, potentially causing occlusion. Affected units have unique serial numbers listed in the recall.
MedtronicMay 10, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Medtronic recalls Intellis AdaptiveStim spinal cord stimulators with Product Number 97715 due to inability to reprogram one device. Affected units have UDI/DI 00643169781719.
Medtr: a short, human brand name for headings (e.g.Mar 28, 2024 - Lower riskMedical device
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
Medtronic recalls its A710 Clinician Programmer Application version 2.0.97 due to potential inability to adjust pain therapy settings, risking inadequate or excessive treatment for patients.
MedtronicDec 19, 2023 - Use cautionMedical device
Medtronic Neuromodulation recalls Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medtronic recalls SynchroMed II programmable pumps (model 8637-20) due to potential failure to resume drug delivery after MRI scans when electromagnetic interference occurs. Affected units have specific serial numbers listed in the recall.
MedtronicNov 13, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Medtronic Neuromodulation recalls Model 97745 controllers used with specific neurostimulators in Korea and Turkey due to incorrect firmware installation for local language interfaces. Affected units have unique serial numbers and UDI/DI codes.
Medtronic NeuromodulationOct 19, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic InterStim Ground Pad REF 041826
Medtronic recalls InterStim Ground Pad REF 041826 due to incorrect expiration date labeling. Affected units may have safety risks if used beyond the correct date.
MedtronicJul 6, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medtronic recalls A901 Communication Manager software for Intellis Neurostimulation System. Missing update for A710 Clinician Programmer causes compatibility issues. Affected units have specific serial numbers.
Medtronic NeuromodulationJun 21, 2023 - Use cautionMedical device
Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Medtronic recalls Vanta with AdaptiveStim Implantable Neurostimulator Model 977006 due to potential spinal chord stimulation causing device failure. Two patients reported explant procedures after the issue occurred.
MedtronicJun 6, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling
Medtronic recalls SenSight Extension Tunneler Kit REF B31030 with dual carriers machined on one side, preventing simultaneous extension passage. Affected units have specific serial numbers and UDI/DI codes.
MedtronicMar 17, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls SenSight Connector Plug, Model Number B31061.
Medtronic is recalling a small number of SenSight Connector Plug Model B31061 units due to a discrepancy in the Use By Date label. Affected units have a specific lot number and GTIN.
Medtronic NeuromodulationJan 20, 2023 - Lower riskMedical device
Medtronic Neuromodulation recalls Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Medtronic recalls Vanta/Seqenita LT Clinician Programmer software with error messages like 'Too Many Device Found' and 'Unexpected Device Error Code 1502' for pain therapy systems. Affected units may experience software issues.
Medtronic NeuromodulationDec 3, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable
Medtronic recalls Vanta Clinician Programmer App version 2.0.2455 for pain therapy devices that may show error 1502, preventing programming of implantable neurostimulators.
Medtronic NeuromodulationJul 26, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable
Medtronic recalls Vanta Clinician Programmer App version 2.0.2455 for potential connection issues with patients using multiple neurostimulators. This software update may prevent proper communication with implantable devices.
Medtronic NeuromodulationJul 26, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Medtronic recalls LEAD 3387S-40 STIMLOC DBS devices due to a discrepancy between Use By Dates on the product and kit labels. Affected units may have expired components.
MedtronicMay 27, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Medtronic recalls Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication issues with clinical programmer systems. Affected devices may not function properly.
MedtronicMar 30, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with
Medtronic recalls Vanta INS Implantable Neurostimulators with AdaptiveStim Technology that may not communicate properly with clinical or patient programming systems. Affected models include specific serial numbers and expiration dates listed in the recall notice.
MedtronicMar 30, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator,
Medtronic recalls InterStim therapy systems for urinary control with software that loses patient data. Affected models include TH90Q01, TH90QFA, TH90PFA, TH90GFA, TH90G01, A51300, and A52300. Data entered in patient fields may not be retained, showing a 'Data Lost' notification.
MedtronicFeb 28, 2022 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712),
Medtronic recalls wireless rechargers (WR9200) for RestoreUltra and RestoreSensor devices that become unresponsive if charging steps aren't followed. Affected units include specific implantable neurostimulators.
MedtronicNov 4, 2021 - Use cautionMedical device
Medtronic Neuromodulation recalls Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Medtronic recalls Model B35200 Percept PC BrainSense Implantable Neurostimulators that may become unresponsive during cardioversion procedures, potentially causing circuit damage. Affected units have specific serial numbers listed in the recall.
MedtronicOct 19, 2021 - Lower riskMedical device
Medtronic Neuromodulation recalls Clinician Programmer Application (CPA) model A610 Clinician Software Application
Medtronic recalls Clinician Programmer Application software versions 3.0.1048-1081 for potential software anomalies. Affected users should check their software version and contact Medtronic for updates.
Medtronic NeuromodulationSep 23, 2021 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medtronic recalls Vectris SureScan MRI devices with specific catalog numbers due to incorrect lead electrode spacing information on packaging. This could lead to improper use during MRI procedures.
MedtronicJul 9, 2021 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256
Recall of Medtronic StimLoc Burr Hole Covers with specific part numbers and lots due to excess nylon flash. Consumers should check their product details to determine if affected.
MedtronicJun 2, 2021 - Stop using nowMedical device
Medtronic Neuromodulation recalls Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable
Medtronic recalls Intellis Model 97755 rechargeers due to potential unintended heating. Affected units charge Medtronic neurostimulators with specific serial numbers. Stop using immediately to prevent injury.
MedtronicMar 25, 2021 - Lower riskMedical device
Medtronic Neuromodulation recalls A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200
Medtronic recalls specific versions of its Percept PC clinician programmer software due to cycling and log fill problems that could cause crashes when copying settings or reading logs.
MedtronicMar 9, 2021 - Lower riskMedical device
Medtronic Neuromodulation recalls Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep
Medtronic recalls Percept PC implantable neurostimulators due to software failure preventing device connection. Affected units have specific model and serial numbers.
Medtronic NeuromodulationNov 19, 2020 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product
Medtronic recalls Intellis Spinal Cord Stimulator model A710 software version 1.3.80 due to inability to program the implantable neurostimulation device. Affected users should contact Medtronic for assistance.
MedtronicNov 12, 2020 - Lower riskMedical device
Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medtronic recalls version 1.0.4232 of the Restore Clinician Programmer Application Software (model A71100) due to compatibility issues with some legacy software, preventing communication with implanted neurostimulators.
Medtr: a short, human brand name for headings (e.g. "Trsmima")Jul 17, 2020 - Lower riskMedical device
Medtronic Neuromodulation recalls Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Medtronic recalls Synchromed II programmable pumps with model numbers 8637-20 and 8637-40 due to potential foreign particles in the motor assembly that could cause motor stalls. Affected units have specific serial numbers listed in the recall notice.
Medtronic NeuromodulationOct 11, 2019 - Lower riskMedical device
Medtronic Neuromodulation recalls InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model
Medtronic recalls InterStim systems with model numbers TH90G01, TH90GFA, TH90G02, TH90G03 due to potential unexpected stimulation during programming. Affected users should contact Medtronic for details.
MedtronicMay 15, 2019 - Lower riskMedical device
Medtronic Neuromodulation recalls Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The
Medtronic recalls Vectris Trial Screening Lead Kits (models 977D160 and 977D260) due to a potential manufacturing defect in the curved tip introducer needle that may cause difficulty advancing or withdrawing the lead during spinal cord stimulation implantation.
MedtronicMay 25, 2018 - Use cautionMedical device
Medtronic Neuromodulation recalls Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI:
Medtronic recalls specific models of Ascenda Intrathecal Catheters due to potential kinking at the pump connection, which could cause drug delivery issues.
MedtronicSep 21, 2017 - Lower riskMedical device
Medtronic Neuromodulation recalls Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The
Medtronic is recalling Synchromed II Model 8637 pumps with 20mL and 40mL reservoirs that may experience motor stall from corrosion. These devices are not implanted and require replacement.
MedtronicAug 9, 2017
Medtronic Neuromodulation recall questions
How many recalls has Medtronic Neuromodulation had?
59 recalls from Medtronic Neuromodulation are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Medtronic Neuromodulation recall?
Medtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for, dated May 13, 2026. Every Medtronic Neuromodulation recall is listed on this page, newest first.
Why are Medtronic Neuromodulation products recalled?
The most common reasons on record: Software issues were identified in application version 2.x. (4).
What should I do if I have a recalled Medtronic Neuromodulation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic Neuromodulation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.