Z-1272-2008

Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD...

Name: Z-1272-2008 Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD...
Creator: Edwards Lifesciences, Llc
Published: 2007-12-05
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2007-12-05 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, Llc began a recall of Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Edwards Lifesciences LLC, Irvine, CA 92614 on 2007-12-05. The reason FDA records is "Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1272-2008
Status: Terminated
Initiated: 2007-12-05
Posted: 2008-07-02
Terminated: 2012-01-11
Recalling firm: Edwards Lifesciences LLC
Product: Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
Root cause tag: packaging
FDA 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 in commerce: 10 UNITS
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: FR6H0161

Product code FGE

K053404Class IILifestent Flexstart Biliary Stent SystemEdwards Lifesciences, LLC / cleared 2005-12-21

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)