Recall Z-0992-2007 ยท DXE Catheter, Embolectomy
Ev3, Inc
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter
| Date | Jul 11, 2007 (initiated May 18, 2007) |
| Status | Terminated |
| Reason | Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. |
| Root cause | Other |
| Action | Letter May 18, 2007. |
| Quantity | 23 units |
| Distribution | Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER Microvena Corp., Mar 6, 1998 |