Recall Z-0295-2022 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
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.
| Date | Nov 4, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | The recalling firm issued undated letters on 11/4/2021 via USPS Priority Shipping. The recalling firm has three different letters addressed to the Healthcare Professional depending upon the type of device the wireless recharger is used with (InterStim Micro, product number RS5200; Activa RC, product number RS6200; or RestoreUltra & RestoreSensor, Product number RS7200, which is currently not distributed in the U.S. at this time). The letter gives an issue overview and provides requested actions. Those actions include reinforcing the instructions in the enclosed Patient Quick User Guide wit |
| Quantity | 10 devices |
| Distribution | US Nationwide, including PR. There was government distribution but no military distribution was identified. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.