Medtronic Neuromodulation recalls
Medtronic Neuromodulation appears in 98 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 98 |
|---|---|
| Published | 2012-12-19 to 2026-06-03 |
| By agency | FDA Device (98) |
| By classification | Class II (83), Class I (14), Class III (1) |
| By status | ongoing (52), terminated (45), completed (1) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation
Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. - Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation
Reason: A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A C…
FDA Device · Class II · 2026-05-20 · Medtronic Neuromodulation
Reason: Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases,… - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation
Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. - Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US…
FDA Device · Class II · 2025-12-31 · Medtronic Neuromodulation
Reason: Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symp… - Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Device · Class II · 2025-05-07 · Medtronic Neuromodulation
Reason: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and… - Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) n…
FDA Device · Class II · 2025-04-16 · Medtronic Neuromodulation
Reason: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. - A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System
FDA Device · Class II · 2025-04-09 · Medtronic Neuromodulation
Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation
Reason: Software issues were identified in application version 2.x. - SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app ver…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation
Reason: Software 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 SMSNG and PROG CT900E…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation
Reason: Software 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 with the A810 CP app…
FDA Device · Class II · 2025-01-08 · Medtronic Neuromodulation
Reason: Software issues were identified in application version 2.x. - Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neur…
FDA Device · Class II · 2024-11-20 · Medtronic Neuromodulation
Reason: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. - SynchroMed II Infusion Pump
FDA Device · Class II · 2024-10-30 · Medtronic Neuromodulation
Reason: Potential for error and inability to interrogate pump due to data corruption in the pump memory. - Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300
FDA Device · Class II · 2024-10-30 · Medtronic Neuromodulation
Reason: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. - Vanta Implantable Neurostimulator (INS), Model 977006
FDA Device · Class II · 2024-10-23 · Medtronic Neuromodulation
Reason: Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. - Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and…
FDA Device · Class II · 2024-09-18 · Medtronic Neuromodulation
Reason: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. - A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.463…
FDA Device · Class II · 2024-07-31 · Medtronic Neuromodulation
Reason: Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. - Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm)
FDA Device · Class II · 2024-07-24 · Medtronic Neuromodulation
Reason: Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead… - Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
FDA Device · Class II · 2024-05-08 · Medtronic Neuromodulation
Reason: inability to reprogram one device - Model A710 Intellis Clinician Programmer Application, version 2.0.97
FDA Device · Class II · 2024-01-31 · Medtronic Neuromodulation
Reason: Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability fo… - Medtronic SynchroMed II, Model 8637-40, Programmable pump
FDA Device · Class II · 2024-01-03 · Medtronic Neuromodulation
Reason: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug de… - Medtronic SynchroMed II, Model 8637-20, Programmable pump
FDA Device · Class II · 2024-01-03 · Medtronic Neuromodulation
Reason: Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug de… - Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
FDA Device · Class II · 2023-11-29 · Medtronic Neuromodulation
Reason: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. - LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40
FDA Device · Class II · 2023-11-08 · Medtronic Neuromodulation
Reason: There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label. - SenSight Connector Plug, Model Number B31061
FDA Device · Class II · 2023-10-25 · Medtronic Neuromodulation
Reason: Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label. - Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators
FDA Device · Class II · 2023-10-11 · Medtronic Neuromodulation
Reason: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inabilit… - Medtronic InterStim Ground Pad REF 041826
FDA Device · Class II · 2023-08-16 · Medtronic Neuromodulation
Reason: Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date. - A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application
FDA Device · Class II · 2023-08-02 · Medtronic Neuromodulation
Reason: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not availa… - Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006
FDA Device · Class II · 2023-07-05 · Medtronic Neuromodulation
Reason: A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue… - Medtronic SenSight Extension Tunneler Kit, REF B31030
FDA Device · Class II · 2023-04-26 · Medtronic Neuromodulation
Reason: Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously. - Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" - Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" - Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" - Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" - Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
FDA Device · Class II · 2023-01-18 · Medtronic Neuromodulation
Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303" - Vanta Clinician Programmer Application, Model A71200
FDA Device · Class II · 2022-08-31 · Medtronic Neuromodulation
Reason: Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurost… - Vanta Clinician Programmer Application, Model A71200
FDA Device · Class II · 2022-08-31 · Medtronic Neuromodulation
Reason: Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implante… - Percept BrainSense Implantable Neurostimulator (INS), Model B35200
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation
Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. - Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation
Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. - Vanta INS Implantable Neurostimulator
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation
Reason: The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. - MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q…
FDA Device · Class II · 2022-05-04 · Medtronic Neuromodulation
Reason: There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed. - Model B35200 - Percept PC BrainSense Implantable Neurostimulator
FDA Device · Class II · 2022-01-05 · Medtronic Neuromodulation
Reason: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbea… - Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neuros…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed. - Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimula…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed. - Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model…
FDA Device · Class II · 2021-12-01 · Medtronic Neuromodulation
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed. - Clinician Programmer Application (CPA) model A610 Clinician Software Application
FDA Device · Class II · 2021-11-10 · Medtronic Neuromodulation
Reason: A software anomaly may occur with the clinician programmer application. - 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 Device · Class II · 2021-08-18 · Medtronic Neuromodulation
Reason: Excess nylon flash on the clip. - Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
FDA Device · Class II · 2021-08-04 · Medtronic Neuromodulation
Reason: Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling. - Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with A…
FDA Device · Class II · 2021-05-12 · Medtronic Neuromodulation
Reason: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.