Recall Z-0052-2007
AGA Medical Corporation · initiated June 1, 2006
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.
Codes / lots: Lot number M06B01-52, serial numbers 190477 - 190494
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: Other
Action taken
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.
Details
- Recall number
- Z-0052-2007
- Initiated
- June 1, 2006
- Posted by FDA
- October 20, 2006
- Terminated
- April 1, 2007
- Product code
- MLV – Transcatheter Septal Occluder
- Quantity
- 18
- Distribution
- Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
- Recalling firm
- AGA Medical Corporation, Golden Valley, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0053-2007 | AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm…AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO… | 06/01/2006Terminated |