Recall Z-0053-2007 ยท MLV Transcatheter Septal Occluder
AGA Medical Corporation
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.
| Date | Oct 20, 2006 (initiated Jun 1, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 18 |
| Distribution | Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.