Recall Z-0295-2022— Medtronic Neuromodulation

Name: FDA recall Z-0295-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-04

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2021-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm: Medtronic Neuromodulation
Classification: Class II
Status: Ongoing
Initiated: 2021-11-04
Firm location: Minneapolis, MN, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.