Restore Clinician Programmer Application Software — Class II medical device recall Z-2657-2023
Terminated recall by Medtronic Neuromodulation, reported 2023-10-11, distributed nationwide. The original version of the A71100 Restore Clinician Programmer Application has been identified to have a comp
| Recall number | Z-2657-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2020-07-17 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Terminated | 2024-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, SG |
| Quantity | 2,408 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000273668 |
| Model numbers | A71100 |
Product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Reason for recall
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
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-2657-2023. 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.