Eon Mini — Class II medical device recall Z-1739-2013
Terminated recall by St. Jude Medical, reported 2013-07-24, distributed nationwide. St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associ
| Recall number | Z-1739-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Plano, TX, United States |
| Recall initiated | 2012-07-26 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CL, CN, CO, GB, IE, IL, IN, KR, MX, MY, SA, SG, ZA |
| Quantity | 70,638 |
Product
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated 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: failed back surgery syndrome, intractable low back and leg pain.
Reason for recall
St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica
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-1739-2013. 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.