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 Microcatheter, one Microsnare Introducer and one torque device. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Microcatheter, one Microsnare Introducer and one torque device.
Lot Codes / Batch Numbers
Model SK400, Lot number 277755, Model KS701, Lot number 575327
Products Sold
Model SK400, Lot number 277755; Model KS701, Lot number 575327
A medical device manufacturer is recalling Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, VA, WA
Page updated: Jan 10, 2026