Medtronic Neuromodulation 2025-12-31 Health serious FDA
Health · FDA · Recall #FDA-Z-0996-2026
Restore Clinician Programmer Application (CP App), Model A71100 used with the following… Recall
Issued December 31, 2025 · Medtronic Neuromodulation
In December 2025, Medtronic Neuromodulation recalled the Restore Clinician Programmer Application (CP App), Model A71100 used with the following…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Restore Clinician Programmer Application (CP App), Model A71100 used with the following… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Neuromodulation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Neuromodulation
- Category
- Health
- Recall date
- December 31, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil,
- Recall number
- FDA-Z-0996-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Neuromodulation has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.