—#65468

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

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K053404
Affected lot / code info: Model EX080801CD; Lot FR6K0319

Why it was recalled

Failure to deploy.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, Llc
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Nationwide including states of OK, GA, CA WI, MO, and LA

Timeline

Recall initiated: 2007-03-19
Posted by FDA: 2007-11-28
Terminated: 2012-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.