Events

Recall of Device Recall AMPLATZER PFO 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
    35814
  • Event Risk Class
    Class 2
  • Event Number
    Z-0053-2007
  • Event Initiated Date
    2006-06-01
  • Event Date Posted
    2006-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48567
  • 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 - Product Code MLV
  • Reason
    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
    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.

Device

Device Recall AMPLATZER PFO Occluder
  • Model / Serial
    Lot number M06B01-58, serial numbers 190495 - 190512
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • Product Description
    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

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