FDA Device recall Z-2657-2023
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators
- FDA Device
- Class II
- terminated
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators by Medtronic Neuromodulation, citing the original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2657-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-17 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Reason
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.
Identifiers
| code_info | Version 1.0.4232, UDI-DI 00763000273668. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2657-2023%22
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