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U.S. Department of Health and Human Services

Class 3 Device Recall AMPLATZER Duct Occluder

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  Class 3 Device Recall AMPLATZER Duct Occluder see related information
Date Initiated by Firm September 06, 2005
Date Posted January 31, 2006
Recall Status1 Terminated 3 on December 26, 2006
Recall Number Z-0465-06
Recall Event ID 33406
Product Classification Occluder, Patent Ductus, Arteriosus - Product Code MAE
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.
Code Information all lots
Recalling Firm/
Manufacturer
AGA Medical Corporation
682 Mendelssohn Ave N
Golden Valley MN 55427-4306
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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