—#73560

Product

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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: Lot Numbers: FR6H0214, and RFR6J0220

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2008-08-29
Posted by FDA: 2008-10-10
Terminated: 2012-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.