Medtronic Wireless Recharger Model WR9200 Becomes Unresponsive on Improper Use
Medtronic is recalling the Wireless Recharger Model WR9200 used with RestoreUltra and RestoreSensor neurostimulator implants. The recharger becomes unresponsive if charging instructions from the user guide are not followed correctly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device for implanted medical systems. No reported illnesses or injuries, but recharger malfunction could prevent patients from adequately charging their neurostimulator systems. This risk-of-harm scenario without reported injury classifies as High per the severity rubric.
Plain-English summary
Medtronic Neuromodulation is recalling the Wireless Recharger Model WR9200 and WR9220, included in the RS7200 Recharger Kit, for use with RestoreUltra, RestoreSensor, Restore Ultra SureScan MRI, and RestoreSensor SureScan MRI implantable neurostimulator systems.
The recharger becomes unresponsive if the charging steps indicated in the Recharger Patient User Guide are not followed correctly. This malfunction may prevent patients from adequately charging their implanted neurostimulator system.
The recall affects approximately 10 devices distributed nationwide in the United States and Puerto Rico.
Patients with affected devices should consult their Recharger Patient User Guide and ensure they are following proper charging procedures. Patients with questions should contact Medtronic Neuromodulation.
The recalled product
- 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.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- charging-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 00763000217921
Distribution
Distributed nationwide across the United States.
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