Recall Z-0463-06 ยท MAE Occluder, Patent Ductus, Arteriosus
AGA Medical Corporation
AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occ
| Date | Jan 31, 2006 (initiated Sep 6, 2005) |
| Status | Terminated |
| Reason | The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream. |
| Root cause | Other |
| Action | User facilities and distributors were notified via email beginning 09/06/05. Additionally a hard copy of the recall letter was sent via certified mail or Federal Express. AGA requests that the Response Form be completed and faxed or emailed back to them. AGA Medical staff will assist users in returning product distributed within the US. |
| Quantity | 18,725 total |
| Distribution | OUS to the following countries: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Isreal, Italy, Jordan, Korea, Kuwait, Malaysia, Mexico, Morocco, Netherl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.