Class 2 Device Recall Amplatz Goose Neck Snare Kit

• Date Initiated by Firm: May 18, 2007
• Date Posted: July 11, 2007
• Recall Status: Terminated on October 17, 2008
• Recall Number: Z-0992-2007
• Recall Event ID: 38052
• 510(K)Number: K972511
• Product Classification: endovascular instrument - Product Code DXE
• Product: 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
• Code Information: Lot # 1650307
• Recalling Firm/ Manufacturer: Ev3, Inc; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: 763-398-7000
• Manufacturer Reason for Recall: Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.
• FDA Determined Cause: Other
• Action: Letter May 18, 2007.
• Quantity in Commerce: 23 units
• Distribution: Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = DXE