Z-0294-2022 Class II Ongoing
FDA device recall Z-0294-2022 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: 6,406 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
- 6,406 devices
Product Description
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
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 00763000185152