Eon Mini - 3721 (Charger). Product Usage: Eon Mini system 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.

Recall Insight

This FDA Devices action (record #Z-1739-2013) was formally reported on July 24, 2013, with the manufacturer initiating the action on July 26, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. St. Jude Medical is listed as the recalling firm, operating out of Plano, TX. Federal records list the affected scope as 70,638 (combined total of the Eon and the Eon Mini systems).

The documented reason for this recall is: St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their s… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, S…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.