Eon Mini Neurostimulation — Class II medical device recall Z-1983-2012
Terminated recall by Advanced Neuromodulation Systems Inc., reported 2012-07-18, distributed nationwide. The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due
| Recall number | Z-1983-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Neuromodulation Systems Inc., Plano, TX, United States |
| Recall initiated | 2011-12-19 |
| Classified | 2012-07-10 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2015-07-24 |
| 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, KR, MX, NL, SA, SE, SG, TR, ZA |
| Model numbers | 3788 |
Product
Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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
The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin
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-1983-2012. 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.