Z-1983-2012Class II

Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of...

Name: Z-1983-2012 Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of...
Creator: Advanced Neuromodulation Systems Inc.
Published: 2011-12-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-12-19 / Terminated / root cause: manufacturing process

FDA source

Advanced Neuromodulation Systems Inc. began a recall of 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... on 2011-12-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1983-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-19
Posted: 2012-07-10
Terminated: 2015-07-24
Recalling firm: Abbott Medical
Product: 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 code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, customers should contact their St. Jude Medical Representative. If device replacement is required due to IPG failure related to this voluntary recall notice, St. Jude Medical will provide a replacement IPG at no charge. For questions regarding this recall call 972-309-2154.
Quantity in commerce: 25, 255 devices
Distribution: 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.
Product codes and lots: Model Number 3788. All lots manufactured prior to September 20, 2010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-10

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)