Z-0025-2013Class II

The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that...

Name: Z-0025-2013 The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that...
Creator: Advanced Neuromodulation Systems Inc.
Published: 2012-09-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-09-04 / Terminated / root cause: manufacturing process

FDA source

Advanced Neuromodulation Systems Inc. began a recall of The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four... on 2012-09-04. FDA classified it as Class II and gives the reason as "Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of...". 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-0025-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-04
Posted: 2012-10-09
Terminated: 2014-05-12
Recalling firm: Abbott Medical
Product: The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. 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 code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.
Quantity in commerce: 56 units
Distribution: US Nationwide Distribution
Product codes and lots: Eon Mini - 3788 (IPG), Multiple Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0025-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0025-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

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)