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Recall Observatory FDA recall evidence

Device product

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

Z-0293-2022

November 04, 2021

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 88953
Status
Ongoing
Classification
Class II
Quantity
10,081 devices
Official record key
device-enforcement:Z-0293-2022

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 00763000186265

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.