Z-0179-2008

Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM...

Name: Z-0179-2008 Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM...
Creator: Edwards Lifesciences, Llc
Published: 2007-03-19
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2007-03-19 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, Llc began a recall of Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards... on 2007-03-19. The reason FDA records is "Failure to deploy". 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-0179-2008
Status: Terminated
Initiated: 2007-03-19
Posted: 2007-11-28
Terminated: 2012-03-26
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Failure to deploy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.
Quantity in commerce: 12 units
Distribution: Nationwide including states of OK, GA, CA WI, MO, and LA
Product codes and lots: Model EX080801CD; Lot FR6K0319

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)