FDANovember 4, 2021device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic neuromodulationmedtronic

UPCs

00763000217921

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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