St. Jude Medical: Medical Device Recall in 2013 - (Recall #: Z-1739-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 26, 2012

Date Posted: July 24, 2013

Recall Number: Z-1739-2013

Event ID: 63109

Reason for Recall:

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 spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica

Status: Terminated

Product Quantity: 70,638 (combined total of the Eon and the Eon Mini systems)

Code Information:

All serial numbers manufactured

Distribution Pattern:

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, South Africa, South Korea, Switzerland and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated