Z-0053-2007

AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The...

Name: Z-0053-2007 AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The...
Creator: AGA Medical Corporation
Published: 2006-06-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-06-01 / Terminated / root cause: labeling and UDI

FDA source

AGA Medical Corporation began a recall of 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... on 2006-06-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0053-2007
Status: Terminated
Initiated: 2006-06-01
Posted: 2006-10-20
Terminated: 2007-04-01
Recalling firm: Abbott Medical
Product: 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.
Product code: MLV Transcatheter Septal Occluder
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Product codes and lots: Lot number M06B01-58, serial numbers 190495 - 190512

Product code MLV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)