Recall Z-0894-06 ยท DXE Catheter, Embolectomy
Ev3, Inc
Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Mi
| Date | Jun 2, 2006 (initiated Aug 16, 2005) |
| Status | Terminated |
| Reason | ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled. |
| Root cause | Other |
| Action | The recall was initiated on August 16, 2005. All units distributed have been accounted for and the firm completed the recall on December 29, 2005. The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement. |
| Quantity | 58 |
| Distribution | AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901502 | AMPLATZ GOOSE-NECK SNARE Microvena Corp., Dec 3, 1990 |