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Medtronic Neuromodulation

Medtronic Neuromodulation Recalls

All product recalls associated with Medtronic Neuromodulation.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 83 recalls

Restore Clinician Programmer Application (CP App), Model ... (Medtronic Neuromodulation) – software issue where a device reset m... (2025)

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 symptoms. Resolution would require surgical replacement of the INS.

FDANov 20, 2025Nationwide• Medtronic Neuromodulation

Enhanced Verify Handset (Medtronic) – Communication Malfunction (2025)

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 a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

FDAApr 3, 2025Nationwide• Medtronic Neuromodulation

Stimulation RC Programmer (Medtronic) – Software Communication Fault (2025)

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There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

FDAMar 4, 2025Nationwide• Medtronic Neuromodulation

A820 myPTM Software (Medtronic) – App Interaction Delay (2025)

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

FDAJan 9, 2025Nationwide• Medtronic Neuromodulation

SynchroMed Implantable Pumps (Medtronic) – Software Issues (2024)

Software issues were identified in application version 2.x.

FDANov 21, 2024Nationwide• Medtronic Neuromodulation

Percept RC Neurostimulator (Medtronic) – Programming Compatibility (2024)

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.

FDASep 24, 2024Nationwide• Medtronic Neuromodulation

Medtronic Recharger Kits (Medtronic) – Charging Session Issue (2024)

The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

FDASep 18, 2024Nationwide• Medtronic Neuromodulation

SynchroMed II Infusion Pump (Medtronic) – Memory Corruption (2024)

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

FDASep 11, 2024Nationwide• Medtronic Neuromodulation

Vanta Neurostimulator (Medtronic) – Battery Life Concern (2024)

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

FDAAug 21, 2024Nationwide• Medtronic Neuromodulation

Handset with Communicator (Medtronic) - Pairing Issue (2024)

A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.

FDAJun 17, 2024Nationwide• Medtronic Neuromodulation

A610 Clinician Programmer (Medtronic) – MRI Limitation (2024)

Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

FDAMay 15, 2024Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic Ascenda Intrathecal Catheter, Models: a) 8780...

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 to catheter occlusion.

FDAMay 10, 2024Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Intellis AdaptiveStim Product Number 97715, Spinal Cord S...

inability to reprogram one device

FDAMar 28, 2024IN• Medtronic Neuromodulation

Medtronic Neuromodulation: Model A710 Intellis Clinician Programmer Application, ver...

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 for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

FDADec 19, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: 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 delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

FDANov 13, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Model 97745 Controller used with Models 97715 and 97716 I...

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

FDAOct 19, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: 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.

FDAJul 6, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: A901 Communication Manager Application, used in conjuncti...

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 available for download.

FDAJun 21, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Vanta with AdaptiveStim Implantable Neurostimulator, Mode...

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 from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

FDAJun 6, 2023Nationwide• Medtronic Neuromodulation

Medtronic Neuromodulation: Medtronic SenSight Extension Tunneler Kit, REF B31030; Th...

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.

FDAMar 17, 2023Nationwide• Medtronic Neuromodulation