AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm 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.
FDA Recall Z-0053-2007 · Posted 2006-10-20
Recalling FirmAGA Medical Corporation
Recall StatusTerminated
Product CodeMLV
Date Initiated2006-06-01
Date Terminated2007-04-01
Product Quantity18
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. The affected product was not distributed within the United States and does not affect U.S. consignees.
Firm 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.
Root Cause
Other
Distribution Pattern
Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.