Z-0080-2009

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine...

Name: Z-0080-2009 Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine...
Creator: Bard Peripheral Vascular Inc
Published: 2008-08-29
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2008-08-29 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100601CD. The LifeStent... on 2008-08-29. The reason FDA records is "Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0080-2009
Status: Terminated
Initiated: 2008-08-29
Posted: 2008-10-10
Terminated: 2012-04-06
Recalling firm: Bard Peripheral Vascular Inc
Product: Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The customer letters for the tip to sheath gap were sent on 8/29/2008 with return receipt. The letter advises that C.R. Bard has determined that some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. Per the letter, the firm's analysis has determined that a gap between the tip of the delivery system and the delivery system sheath may be associated with difficult advancement to the treatment site. Users are instructed to inspect all devices to verify that there is not a gap between the tip and sheath (orange colored guidewire lumen is visible), prior to use and to not use any devices that exhibit a tip to sheath gap condition. If devices that exhibit a tip to sheath gap are identified, customers are advised to call Customer Service at 1-800-321-4254 to return the device and a replacement will be provided at no cost. The letter also advises that the Instructions for Use for the LifeStent FlexStar System will be updated to include the inspection step which is provided in the letter.
Quantity in commerce: 281 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: R58285865, R58312972, 58337682, 58415748, FR6J0229, and RFR6K0303

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)