Medtronic RestoreUltra — Class II medical device recall Z-0278-2014
Terminated recall by Medtronic Neuromodulation, reported 2013-11-20, distributed nationwide. Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the
| Recall number | Z-0278-2014 |
|---|---|
| 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 | 2013-11-14 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2015-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AW, BE, BG, BR, CA, 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.
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).
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-0278-2014. 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.