Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Eon and Eon Mini charging system Recalled by St. Jude Medical Due to There is issues of warmth or heating at...

Date: November 30, 2012
Company: St. Jude Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical directly.

Affected Products

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.

Quantity: 75,663

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About St. Jude Medical

St. Jude Medical has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report