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Recall Observatory FDA recall evidence

Device product

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

Z-0295-2022

November 04, 2021

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 88953
Status
Ongoing
Classification
Class II
Quantity
10 devices
Official record key
device-enforcement:Z-0295-2022

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 00763000217921

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.