Agency classClass IIOur severity:High FDA (Devices)·Z-0294-2022·Announced 2021-12-01

Medtronic Wireless Recharger for Activa RC May Become Unresponsive

Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: A recharger failure for an implanted neurostimulator presents a risk of harm if the device cannot be properly charged. While the source reports no injuries, this is classified as a risk-of-harm medical device product without reported illness, meeting the criteria for Score 3 per the rubric.

Plain-English summary

The Medtronic Wireless Recharger Model WR9200, included in the RS6200 Recharger Kit, is used to charge the Activa RC Model 37612 implantable neurostimulator. Approximately 6,406 units have been distributed nationwide, including Puerto Rico. The product is identified by UDI 00763000185152.

The wireless recharger may become unresponsive during charging if the specific charging steps outlined in the Recharger Patient User Guide are not followed. A recharger that becomes unresponsive cannot charge the implanted neurostimulator.

Patients using the Activa RC neurostimulator and their healthcare providers should ensure all charging instructions in the Recharger Patient User Guide are followed precisely. Patients experiencing an unresponsive recharger should contact Medtronic Neuromodulation for assistance. The recalling manufacturer is Medtronic Neuromodulation.

The recalled product

Product: Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulator Recharger
Hazard: device-malfunction
unresponsive-recharger
Affected units: 6,406

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 00763000185152

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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