Recall Z-0829-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PT
| Date | May 3, 2006 (initiated Dec 29, 2005) |
| Status | Terminated |
| Reason | IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001) |
| Root cause | Other |
| Action | On March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents. |
| Quantity | 6 devices |
| Distribution | AR, GA, IN, MA, TN, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993904 | INTRASTENT DOUBLESTRUT LD Intratherapeutics, Inc., Feb 1, 2000 |