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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0294-2022 |
Event ID | 88953 |
Event Description | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator. |
Product Type | Devices |
Distribution | US Nationwide, including PR. There was government distribution but no military distribution was identified. |
Quantity | 6,406 devices |
Recall 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. |
Device Classification | 20211201 |
Device Code Info | UDI 00763000185152 |
Center Classification Date | 20211124 |
Recall Initiation Date | 20211104 |
Recalling Firm | Medtronic Neuromodulation |
Initial Notification | Letter |
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