Z-0295-2022 Class II Ongoing
FDA device recall Z-0295-2022 was initiated by Medtronic Neuromodulation on November 4, 2021 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 10 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- November 4, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 devices
Product 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Code Information
UDI 00763000217921