The Recall Desk
HighFDA (Devices)·Z-0278-2014·Announced 2013-11-20

Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Loss of Stimulation

Medtronic is recalling 64,163 RestoreUltra and RestoreSensor neurostimulators worldwide due to a risk of loss of stimulation when switching program groups.

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 medical device with a functional defect (loss of stimulation) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Neuromodulation is recalling 64,163 units of the RestoreUltra (model 37712) and RestoreSensor (model 37714) Multi-program Rechargeable Neurostimulators for Spinal Cord Stimulation. The recall covers devices distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international markets.

The recall is issued because the devices may experience a loss of stimulation under specific conditions, specifically when switching between groups with multiple programs or creating program groups. The source text notes that 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 or Medtronic for instructions on how to manage the device and restore therapy if necessary.

The recalled product

Product
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Neurostimulator
Hazard
Affected units
64,163

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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