Medtronic Neuromodulation Recall 88953
Description: 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.
Medtronic Neuromodulation Recall 88953 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0295-2022 |
| Event ID | 88953 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide, including PR. There was government distribution but no military distribution was identified. |
| Quantity | 10 devices |
| Recall 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. |
| Device Classification | 20211201 |
| Device Code Info | UDI 00763000217921 |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20211104 |
| Recalling Firm | Medtronic Neuromodulation |
| Initial Notification | Letter |
| Similar To |