Recall Z-0389-2007 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Ev3, Inc
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
| Date | Feb 1, 2007 (initiated Dec 6, 2006) |
| Status | Terminated |
| Reason | Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected. |
| Root cause | Other |
| Action | Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3. |
| Quantity | 2 |
| Distribution | IL, PA |
| 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 |