Recall Z-0084-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100903CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
| Date | Oct 10, 2008 (initiated Aug 29, 2008) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 10 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM Edwards Lifesciences, LLC, Dec 21, 2005 |