AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Oc
FDA device recall Z-0053-2007 · posted 2006-10-20 · Terminated
Recall details
- Recalling firm
- AGA Medical Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLV
- Quantity affected
- 18
- Distribution
- Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
- Date initiated
- 2006-06-01
- Date posted
- 2006-10-20
- Date terminated
- 2007-04-01
- Location
- Golden Valley, MN
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