CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report

Medtronic RestoreUltra recalled by Medtronic Neuromodulation

Medtronic Neuromodulation is recalling Medtronic RestoreUltra, distributed nationwide in the US. The recall was initiated on 30 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers

Quantity recalled64,163

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0278-2014
FDA event ID: 66506
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 30 Sep 2013
FDA classified: 14 Nov 2013
Reported: 20 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

30 Sep 2013	Recall initiated by company
14 Nov 2013	Classified by FDA	+45 days
20 Nov 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.

Where it was distributed

Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Medtronic RestoreUltra recalled?

Yes. Medtronic Neuromodulation recalled Medtronic RestoreUltra on 30 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0278-2014.

Why was it recalled?

Which lots are affected?

all serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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