The Recall Desk
HighFDA (Devices)·Z-0124-2014·Announced 2013-11-06

Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Stimulation Issues

Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.

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 is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' severity category, representing a risk-of-harm product 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. These devices are indicated for the management of chronic, intractable pain of the trunk and/or limbs.

The recall is due to a potential for over-stimulation or stimulation directed to a lead electrode other than what was intended. This issue may occur upon a specific set of conditions, typically related to device recovery from an over-discharge.

The affected devices were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. Medtronic has notified customers regarding this issue.

The recalled product

Product
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of ch
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 →

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