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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLATZER PFO Occluder

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  Class 2 Device Recall AMPLATZER PFO Occluder see related information
Date Initiated by Firm June 01, 2006
Date Posted October 20, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall Number Z-0052-2007
Recall Event ID 35814
Product Classification Occluder - Product Code MLV
Product AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
Code Information Lot number M06B01-52, serial numbers 190477 - 190494
Recalling Firm/
AGA Medical Corporation
682 Mendelssohn Ave N
Golden Valley MN 55427-4306
Manufacturer Reason
for Recall
AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.
FDA Determined
Cause 2
Action Consignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices will be replaced.
Quantity in Commerce 18
Distribution Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
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.