The Recall Desk
HighFDA (Devices)·Z-0279-2014·Announced 2013-11-20

Medtronic Activa Neurostimulators Recalled for Loss of Stimulation

Medtronic is recalling specific Activa rechargeable neurostimulators because they may lose stimulation when switching programs. Therapy can be restored using the Physician Recharge mode.

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: The recall involves a risk-of-harm medical device (loss of stimulation) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Medtronic Neuromodulation is recalling specific models of the Activa Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. The affected models include the Activa PC (model 37601), Activa RC (model 37612), and Activa SC (models 37602 and 37603). The recall involves 62,634 units distributed worldwide, including the United States and numerous international countries.

The recall is due to a potential loss of stimulation that can occur under specific conditions, specifically when switching between groups with multiple programs or creating program groups. According to the source text, therapy can be restored using the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

Patients with these implanted devices should contact their healthcare provider to discuss the recall and determine if their specific device is affected. The manufacturer has notified customers regarding this issue.

The recalled product

Product
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Neurostimulator
Hazard
Affected units
62,634

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)

  • all serial numbers

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 2 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 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Neuromodulation

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Same hazard · loss of stimulation

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