Reported Dec 31, 2025 · Ongoing
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Restore Clinician Programmer Application (CP App), Model A71100
- used with the following programmersCT900A 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
- Lot codes and dates
- CP AppUDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected
- Amount recalled
- 7667 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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