Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Ch

FDA device recall Z-1785-2013 · posted 2013-07-22 · Terminated

Recall details

Recalling firm

St. Jude Medical

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

Action taken

St Jude Medical sent an Important Medical Device Safety Information letter dated November 30, 2012 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a replacement charger for the Eon Mini IPGs is now available and will be provided at no charge. For questions or concerns call St. Jude Medical at 877-650-0367.

Root cause

Device Design

Status

Terminated

Product code

LGW

Quantity affected

75,663

Distribution

Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, G

Date initiated

2012-11-30

Date posted

2013-07-22

Date terminated

2015-11-04

Location

Plano, TX