Recall Z-1329-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3
Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
| Date | Aug 7, 2004 (initiated Jul 9, 2004) |
| Status | Terminated |
| Reason | Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018'). |
| Root cause | Other |
| Action | Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product. |
| Quantity | 10 |
| Distribution | Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc., Nov 21, 2003 |