Eon Mini — Class II medical device recall Z-1836-2013
Terminated recall by St. Jude Medical, reported 2013-08-07, distributed nationwide. As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 repor
| Recall number | Z-1836-2013 |
|---|---|
| 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 | 2013-07-31 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2015-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CO, CY, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IN, IT, JP, MX, NL, SE, TR, ZA |
| Quantity | 34,617 |
| Lot numbers | 326-508 |
Product
Eon Mini - 3788 (IPG), 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
As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne
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-1836-2013. 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.