Medtronic Wireless Recharger for InterStim Micro May Become Unresponsive
Medtronic's wireless recharger for the InterStim Micro implantable neurostimulator may become unresponsive if charging procedures from the user guide are not followed. Approximately 10,081 devices are affected nationwide.
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 implantable device recharger with no reported illnesses or injuries. The hazard—device unresponsiveness if charging steps are not followed—poses theoretical risk to implanted device function but is contingent on user error.
Plain-English summary
Medtronic has recalled the Wireless Recharger Model WR9220 (and WR9200) supplied as part of the RS5200 Recharger Kit used with the InterStim Micro (Model 97810) implantable neurostimulator. Approximately 10,081 devices have been distributed nationwide, including Puerto Rico.
The recharger may become unresponsive if the charging steps described in the Recharger Patient User Guide are not followed correctly. When the recharger does not respond as expected, patients may be unable to recharge their implanted device.
Affected patients are those who use the InterStim Micro with the WR9220 or WR9200 wireless recharger. The devices were distributed throughout the United States and Puerto Rico.
Patients should review the charging steps in their Recharger Patient User Guide and contact Medtronic if their recharger becomes unresponsive or if they have questions about proper use.
The recalled product
- Product
- Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- recharger-malfunction
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 00763000186265
Distribution
Distributed nationwide across the United States.
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