FDA Medical Device Recalls (openFDA)
Advanced Neuromodulation Systems, Inc: Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
- Recall number
- Z-1599-2010
- Recalling firm
- Advanced Neuromodulation Systems, Inc
- Product
- Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
- Status
- Terminated
- Initiated
- 2010-04-23
- Posted
- 2010-05-13
- Terminated
- 2015-07-27
- Reason
- Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
- Root cause
- Manufacturing material removal
- Action
- St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.
- Quantity
- 7 devices
- Distribution
- Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
- Lot, serial or model codes
- Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010032-S023"]
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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