Advanced Neuromodulation Systems Inc.: Medical Device Recall in 2012 - (Recall #: Z-1983-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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: December 19, 2011

Date Posted: July 18, 2012

Recall Number: Z-1983-2012

Event ID: 61151

Reason for Recall:

The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin

Status: Terminated

Product Quantity: 25, 255 devices

Code Information:

Model Number 3788. All lots manufactured prior to September 20, 2010.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated