AUSTRALIAN PRODUCT RECALL

Wireless Recharger Model WR9220 and WR9200 for Rechargeable Implanted Neurostimulator

Published 3 February 2022

Product

Wireless Recharger Model WR9220 and WR9200 RECHARGER KITs InterStim Micro, ACTIVA RC and RestoreUltra & RestoreSensor Product numbers: RS5200, RS6200 and RS7200 ARTGs 121279, 355990 and 366470 The Wireless Recharger (WR9220 and WR9200) is used to recharge the battery of a rechargeable implanted neurostimulator. Rechargers are provided as part of a kit that includes the recharger, dock, USB charging cable, AC power adapter, and drape or belt.  

Why it was recalled

The Medtronic WR9220 and WR9200 Rechargers may become unresponsive when: the product is fully depleted; and placed on the dock; and quickly removed within 20 seconds, interrupting the initialisation routine. When the Wireless Recharger becomes unresponsive, the Wireless Recharger: will not respond to a button press cannot pair with the recharger app the recharger battery indicator will flash continuously when placed on the battery dock. 

Hazard

In the event of an unresponsive Wireless Recharger, the user will not be able to charge their implanted neurostimulator until a replacement Wireless Recharger device is received. This may lead to loss of therapy and the return of symptoms.

Read the official notice ↗

Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.