PlainRecalls
FDA Devices Moderate Class II Ongoing

Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

Reported: December 1, 2021 Initiated: November 4, 2021 #Z-0294-2022

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.

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
6,406 devices
Distribution
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.. Recalled by Medtronic Neuromodulation. Units affected: 6,406 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0294-2022.