St. Jude Medical: Medical Device Recall in 2013 - (Recall #: Z-1836-2013)

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 - 3788 (IPG), 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: August 7, 2013

Recall Number: Z-1836-2013

Event ID: 63108

Reason for Recall:

As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne

Status: Terminated

Product Quantity: 34,617

Code Information:

Multiple lots recalled are the ones with supplier's inner battery lots of 326-508

Distribution Pattern:

Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated