Recall Z-0912-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
| Date | May 31, 2006 (initiated Mar 8, 2006) |
| Status | Terminated |
| Reason | A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter. |
| Root cause | Other |
| Action | ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account. |
| Quantity | 29 |
| Distribution | Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043243 | PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc., Dec 9, 2004 |