Medtronic RestoreUltra — Class II medical device recall Z-0124-2014
Terminated recall by Medtronic Neuromodulation, reported 2013-11-06, distributed nationwide. Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Med
| Recall number | Z-0124-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2013-10-31 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2015-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AW, BE, BG, BR, CH, CL, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KW, LB, LT, LU, LV, MA, MT, MX, NL, NO, OM, PA, PE, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, SV, TN, TR, UA, UY, VE, ZA |
| Quantity | 64,163 |
| Model numbers | 37712, 37714 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0124-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.