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.
This recall has been terminated (originally issued October 20, 2006).
- Company
- Aga Medical Corporation
- Recall Initiated
- June 1, 2006
- Posted
- October 20, 2006
- Terminated
- April 1, 2007
- Recall Number
- Z-0053-2007
- Quantity
- 18
- Firm Location
- Golden Valley, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
Lot / Code Info
Lot number M06B01-58, serial numbers 190495 - 190512
Root 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.