FDA Device recall Z-0295-2022
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model…
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model… by Medtronic Neuromodulation, citing the wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0295-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-04 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
Reason
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Identifiers
| code_info | UDI 00763000217921 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0295-2022%22
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