The Recall Desk
Severity pendingFDA (Devices)·Z-0996-2026·Announced 2025-12-31

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:

Pending LLM rewrite. Source: FDA_DEVICE Z-0996-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
Restore 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 P
Manufacturer
Medtronic Neuromodulation

Distribution

Distributed nationwide across the United States.