FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, Llc: Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
- Recall number
- Z-1257-2008
- Recalling firm
- Edwards Lifesciences, Llc
- Product
- Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
- Status
- Terminated
- Initiated
- 2007-12-05
- Posted
- 2008-07-02
- Terminated
- 2012-01-11
- Reason
- Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
- Root cause
- Packaging process control
- Action
- Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.
- Quantity
- Lot #FR6H0139 - 19 UNITS, FR6H0199 - 6 UNITS
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: FR6H0139 (Exp 2008/08) and FR6H0199 (Exp 2008/08).
- 510(k) numbers
- ["K053404"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- 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