FDA Medical Device Recalls (openFDA)
Advanced Neuromodulation Systems, Inc: Eon Rechargeable Implantable Pulse Generator (IPG) System
- Recall number
- Z-0170-2010
- Recalling firm
- Advanced Neuromodulation Systems, Inc
- Product
- Eon Rechargeable Implantable Pulse Generator (IPG) System
- Status
- Terminated
- Initiated
- 2006-12-22
- Posted
- 2009-11-10
- Terminated
- 2010-07-23
- Reason
- 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
- 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
- 24,750 units total
- Distribution
- Worldwide
- Lot, serial or model codes
- Model number 3701 charging system is an accessory to the 3716 IPG; antennas are not serialized.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010032/S14/"]
- Product code
- LGW
- Firm FEI
- 1627487
- Firm city
- Plano
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28