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.
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FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A C…
FDA Device · Class II · 2026-05-20 · Medtronic Neuromodulation - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation - Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US…
FDA Device · Class II · 2025-12-31 · Medtronic Neuromodulation
All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2657-2023%22
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