Z-1738-2013Class II

Eon - 3701 (Wall Charger) and 3711 (Portable Charger)

Name: Z-1738-2013 Eon - 3701 (Wall Charger) and 3711 (Portable Charger)
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 - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of... on 2012-07-26. FDA classified it as Class II and gives the reason as "St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their...". 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-1738-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2013-07-16
Terminated: 2015-11-18
Recalling firm: Abbott Medical
Product: Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon 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. Eon Mini: 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: St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica
Root cause tag: design
FDA root cause: Device Design
Action: ST. Jude Medical sent an Important Medical Device Safety Information dated July 26, 2012 to affected customers. The letter identifed the affected product, problem and actions to be taken. For questions or concerns contact your ST. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741.
Quantity in commerce: 70,638 (combined total for Eon and Eon mini systems)
Distribution: Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
Product codes and lots: All serial numbers manufactured

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1738-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16
Z-1739-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16

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)