Z-0124-2014Class II

Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable...

Name: Z-0124-2014 Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable...
Creator: Medtronic Neuromodulation
Published: 2013-09-30
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2013-09-30 / Terminated / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic... on 2013-09-30. FDA classified it as Class II and gives the reason as "Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0124-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-30
Posted: 2013-10-31
Terminated: 2015-11-20
Recalling firm: Medtronic Neuromodulation
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 chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Medtronic, sent an "Urgent: Medical Device Correction" letter dated September 2013 entitled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter described the product, problem and actions to be taken. The letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. The customers were instructed to avoid over discharge; if a rechargeable device becomes over discharged, contact Medtronic Patient Services at (1-800-510-6735) to resolve the POR and reduce the likelihood of over stimulation. If you have questions, please contact Medtronic Neurostimulation Technical Services at 1-800-707-0933 weekdays 7am-6pm CST.
Quantity in commerce: 64,163
Distribution: Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, 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.
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-31
Z-0125-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-31

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)