Z-1836-2013Class II

Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain...

Name: Z-1836-2013 Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain...
Creator: St. Jude Medical
Published: 2012-07-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-07-26 / Terminated / root cause: design

FDA source

St. Jude Medical began a recall of 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... on 2012-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1836-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2013-07-31
Terminated: 2015-08-21
Recalling firm: Abbott Medical
Product: 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 code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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
Root cause tag: design
FDA root cause: Device Design
Action: St. Jude Medical sent a Important Medical Device Recall Advisory dated July 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To further assist in your patient care we are providing you with a list of all serial numbers we show have been distributed to you. ( See Attachment A ). Further questions please call (972) 309-2154.
Quantity in commerce: 34,617
Distribution: 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.
Product codes and lots: Multiple lots recalled are the ones with supplier's inner battery lots of 326-508

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1836-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1836-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-31

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)