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Medtronic Neuromodulation Recall 88953

Description: Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

Medtronic Neuromodulation Recall 88953 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0294-2022
Event ID88953
Event DescriptionMedtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Product TypeDevices
DistributionUS Nationwide, including PR. There was government distribution but no military distribution was identified.
Quantity6,406 devices
Recall ReasonThe 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.
Device Classification20211201
Device Code InfoUDI 00763000185152
Center Classification Date20211124
Recall Initiation Date20211104
Recalling FirmMedtronic Neuromodulation
Initial Notification Letter
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