Events

Recall of AMPLATZER Duct Occluder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGA Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33406
  • Event Risk Class
    Class 3
  • Event Number
    Z-0461-06
  • Event Initiated Date
    2005-09-06
  • Event Date Posted
    2006-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41814
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Occluder, Patent Ductus, Arteriosus - Product Code MAE
  • 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.
  • 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.

Device

AMPLATZER Duct Occluder
  • Model / Serial
    all lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Manufacturer Address
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA