Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Brand
Bard Peripheral Vascular Inc
Lot Codes / Batch Numbers
Lot Numbers: FR6J0255, FR6K0341, and R58284565
Products Sold
Lot Numbers: FR6J0255, FR6K0341, and R58284565
Bard Peripheral Vascular Inc is recalling Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LL due to 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 visib. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026