Z-0278-2014Class II

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

Name: Z-0278-2014 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 on 2013-09-30. FDA classified it as Class II and gives the reason as "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...". 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-0278-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-30
Posted: 2013-11-14
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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).
Root cause tag: software
FDA root cause: Software design
Action: In September 2013 Medtronic issued a medical device correction letter titled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. Medtronic field representatives will be updating the model 8870 software application card to version AAR/01, which is contained in the physician programmer. A Physician Reply Form was asked to be signed and returned by fax or mail for acknowledging the receipt of the Urgent Medical Device Correction letter. When the Medtronic field rep updates the software application card of the physicains' programmer, they will complete a Rep Reply For: 8870 Card Update to AAR/01.
Quantity in commerce: 64,163
Distribution: 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.
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0278-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0278-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14
Z-0279-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-14

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)