Medtronic Neuromodulation recalls
35 official recalls and safety alerts involving Medtronic Neuromodulation since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medtronic Neuromodulation or the relevant agency.
- 2026-06-03
USMedtronic Neuromodulation recalls Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and The countries of Austria, France,…Official notice →- 2026-05-20
- US
Medtronic Neuromodulation recalls Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG…
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…
- 2026-01-21
- US
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- 2025-12-31
- US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN…
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…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Argentina, Aruba,…Official notice → - 2025-05-07
- US
Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)
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…
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL,…Official notice → - 2025-04-16
- US
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice → - 2025-04-09
- US
Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2025-01-08
- US
Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP…
Software issues were identified in application version 2.x.
- 2024-11-20
- US
Medtronic Neuromodulation recalls Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable…
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
FDA · DeviceMedtronic NeuromodulationWorldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA,…Official notice → - 2024-10-30
- US
Medtronic Neuromodulation recalls Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
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.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Germany, UK, and Israel.Official notice → - US
Medtronic Neuromodulation recalls SynchroMed II Infusion Pump. Product Number: 8637-20
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the state of Mississippi.Official notice → - 2024-10-23
- US
Medtronic Neuromodulation recalls Vanta Implantable Neurostimulator (INS), Model 977006
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
- 2024-09-18
- US
Medtronic Neuromodulation recalls Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset…
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- 2024-07-31
- US
Medtronic Neuromodulation recalls A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605,…
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2024-07-24
- US
Medtronic Neuromodulation recalls Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
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…
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2024-05-08
- US
Medtronic Neuromodulation recalls Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
inability to reprogram one device
FDA · DeviceMedtronic NeuromodulationInternational distribution in the country of UK.Official notice → - 2024-01-31
- US
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
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…
- 2024-01-03
- US
Medtronic Neuromodulation recalls Medtronic SynchroMed II, Model 8637-20, Programmable pump
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…
- 2023-11-29
- US
Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of S. Korea and Turkey.Official notice → - 2023-11-08
- US
Medtronic Neuromodulation recalls LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
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.
- 2023-10-25
- US
Medtronic Neuromodulation recalls SenSight Connector Plug, Model Number B31061.
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.
- 2023-10-11
- US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
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…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide (there was government and military…Official notice → - 2023-08-16
- US
Medtronic Neuromodulation recalls Medtronic InterStim Ground Pad REF 041826
Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the country of Iran.Official notice → - 2023-08-02
- US
Medtronic Neuromodulation recalls A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
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…
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of Israel and Serbia.Official notice → - 2023-07-05
- US
Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
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…
- 2023-04-26
- US
Medtronic Neuromodulation recalls Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of…
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.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2023-01-18
- US
Medtronic Neuromodulation recalls Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- 2022-08-31
- US
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…
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…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US distribution including in the states of AK, AL,…Official notice → - US
Medtronic Neuromodulation recalls Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators…
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…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2022-06-01
- US
Medtronic Neuromodulation recalls Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice → - US
Medtronic Neuromodulation recalls Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI…
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2022-05-04
- US
Medtronic Neuromodulation recalls MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1)…
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.
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY,…Official notice → - 2022-01-05
- US
Medtronic Neuromodulation recalls Model B35200 - Percept PC BrainSense Implantable Neurostimulator
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…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice → - 2021-12-01
- US
Medtronic Neuromodulation recalls Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor…
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.
FDA · DeviceMedtronic NeuromodulationUS Nationwide, including PR. There was government distribution but no military…Official notice → - 2021-11-10
- US
Medtronic Neuromodulation recalls Clinician Programmer Application (CPA) model A610 Clinician Software Application
A software anomaly may occur with the clinician programmer application.
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide distribution and the countries of…Official notice →