Eon and Eon Mini charging system — Class II medical device recall Z-1785-2013
Terminated recall by St. Jude Medical, reported 2013-07-31, distributed nationwide. There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse ge
| Recall number | Z-1785-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Plano, TX, United States |
| Recall initiated | 2012-11-30 |
| Classified | 2013-07-22 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2015-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LU, MX, NL, PL, SA, SE, SG, TR, ZA |
| Quantity | 75,663 |
| Model numbers | 3701 |
Product
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.
Reason for recall
There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the
Machine access
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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.