Medtronic Neuromodulation
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Neuromodulation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-21FDA-DeviceClass IIA71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- 2025-12-31FDA-DeviceClass IIRestore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
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.
- 2025-05-07FDA-DeviceClass IIEnhanced 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 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.
- 2025-04-16FDA-DeviceClass IIStimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
- 2025-04-09FDA-DeviceClass IIA820 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.
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