Recall Z-0294-2022
Medtronic Neuromodulation · initiated November 4, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Codes / lots: UDI 00763000185152
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.
FDA-determined cause: Other
Action taken
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 with their patients and to attempt to reset the WR if the device appears unresponsive. If the problem is not resolved, then contact information is provided for Medtronic Technical Services. A customer confirmation form dated November 2021 was enclosed to acknowledge the consignee has received the letter.
Details
- Recall number
- Z-0294-2022
- Initiated
- November 4, 2021
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 6,406 devices
- Distribution
- US Nationwide, including PR. There was government distribution but no military distribution was identified.
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0293-2022 Class II | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by…The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the… | 11/04/2021Open, Classified |
| Z-0295-2022 Class II | Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by…The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the… | 11/04/2021Open, Classified |