Medtronic Wireless Recharger Model WR9200 included in the… recallZ-0294-2022 · Medtronic Neuromodulation · initiated Nov 4, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
The recalling firm issued undated letters on 11/4/2021 via USPS Priority Shipping. The recalling firm has three different letters addressed to the Healthcare Professional depending upon the type of device the wireless recharger is used with (InterStim Micro, product number RS5200; Activa RC, product number RS6200; or RestoreUltra & RestoreSensor, Product number RS7200, which is currently not distributed in the U.S. at this time). The letter gives an issue overview and provides requested actions. Those actions include reinforcing the instructions in the enclosed Patient Quick User Guide with their patients and to attempt to reset the WR if the device appears unresponsive. If the problem is not resolved, then contact information is provided for Medtronic Technical Services. A customer confirmation form dated November 2021 was enclosed to acknowledge the consignee has received the letter.
Recall details
- Recall number
- Z-0294-2022
- Status
- Open, Classified
- Initiated by the company
- Nov 4, 2021
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 6,406 devices
- Product code
- MHY
- FDA submissions
- P960009S365
- Distribution
- US Nationwide, including PR. There was government distribution but no military distribution was identified.
Product description
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Code information (models, lots, serial numbers)
UDI 00763000185152
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA RS6200Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88953).
- Z-0293-2022 · Open, ClassifiedMedtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
- Z-0295-2022 · Open, ClassifiedMedtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Mode…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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