Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0294-2022

November 04, 2021

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 88953
Status
Ongoing
Classification
Class II
Quantity
6,406 devices
Official record key
device-enforcement:Z-0294-2022

Official wording

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.

Code information: UDI 00763000185152

Distribution pattern: US Nationwide, including PR. There was government distribution but no military distribution was identified.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.