Recall Z-1785-2013— St. Jude Medical

Class II FDA medical device recall by St. Jude Medical, initiated 2012-11-30, terminated 2015-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.

Recalling firm

St. Jude Medical

Classification

Class II

Status

Terminated

Initiated

2012-11-30

Terminated

2015-11-04

Firm location

Plano, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.