Z-0170-2010

Eon Rechargeable Implantable Pulse Generator (IPG) System

Name: Z-0170-2010 Eon Rechargeable Implantable Pulse Generator (IPG) System
Creator: Advanced Neuromodulation Systems, Inc
Published: 2006-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-12-22 / Terminated / root cause: design

FDA source

Advanced Neuromodulation Systems, Inc began a recall of Eon Rechargeable Implantable Pulse Generator (IPG) System on 2006-12-22. The reason FDA records is "Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system". 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-0170-2010
Status: Terminated
Initiated: 2006-12-22
Posted: 2009-11-10
Terminated: 2010-07-23
Recalling firm: Abbott Medical
Product: Eon Rechargeable Implantable Pulse Generator (IPG) System
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.
Root cause tag: design
FDA root cause: Device Design
Action: 12/22/2006, Marketing Update 5015 was issued to field sales representatives providing information on improving communication between the Internal Pulse Generator and its charger. May 15, 2007, Marketing Update 5022 was issued to field sales representatives to reiterate avoiding contact between the charger antenna and conductive materials and place the preferred side of the charging antenna face-down over the implant. Troubleshooting Guide was created in January 2008 for field sales representatives and technical services departments regarding isolation of the communication issue to the external devices instead of the implanted component. March 25, 2008, the Clinician's Manual was updated adding a recommendation for a minimum depth of pocket for device implantation.
Quantity in commerce: 24,750 units total
Distribution: Worldwide
Product codes and lots: Model number 3701 charging system is an accessory to the 3716 IPG; antennas are not serialized.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)