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U.S. Department of Health and Human Services

Class 3 Device Recall Amplatz Goose Neck Snare

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 Class 3 Device Recall Amplatz Goose Neck Snaresee related information
Date Initiated by FirmAugust 16, 2005
Date PostedJune 02, 2006
Recall Status1 Terminated 3 on December 26, 2006
Recall NumberZ-0894-06
Recall Event ID 34337
510(K)NumberK901502 
Product Classification Microsnare Kit, - Product Code DXE
ProductAmplatz 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.
Code Information Model SK400, Lot number 277755;  Model KS701, Lot number 575327
FEI Number 2183870
Recalling Firm/
Manufacturer		 Ev3, Inc
4600 Nathan Ln N
Plymouth MN 55442-2890
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		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 in Commerce58
DistributionAL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXE
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