Restore Clinician Programmer Application — Class II medical device recall Z-0996-2026
Ongoing recall by Medtronic Neuromodulation, reported 2025-12-31, distributed nationwide. Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this
| Recall number | Z-0996-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2025-11-20 |
| Classified | 2025-12-23 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, ID, IE, IL, IS, IT, JP, KW, LU, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RU, SE, SG, SI, SK, SV, TH, TR, TW, UY, ZA |
| Quantity | 7,667 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000273668 |
| Model numbers | A71100 |
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 PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0996-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.