FDA Medical Device Recalls (openFDA)
AGA Medical Corporation: AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 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 occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.
- Recall number
- Z-0465-06
- Recalling firm
- AGA Medical Corporation
- Product
- AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 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 occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication.
- Status
- Terminated
- Initiated
- 2005-09-06
- Posted
- 2006-01-31
- Terminated
- 2006-12-26
- 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, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Saudia Arabia, Singapore, Slovakia, South Africa, Spain, Sweeden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uruguay, Venezuela, Viet Nam and United Kingdom.
- Lot, serial or model codes
- all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAE
- Firm FEI
- 3005334138
- Firm city
- Golden Valley
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28