AGA Medical Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
AGA Medical Corporation
Lot Codes / Batch Numbers
Lot number M06B01-52, serial numbers 190477 - 190494
Products Sold
Lot number M06B01-52, serial numbers 190477 - 190494
AGA Medical Corporation is recalling AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile E due to AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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
IN
Page updated: Jan 10, 2026