Events

Recall of Device Recall ATS Mechanical Heart Valve

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

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
    28356
  • Event Risk Class
    Class 2
  • Event Number
    Z-0634-04
  • Event Initiated Date
    2004-02-18
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31642
  • 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
    Heart-Valve, Mechanical - Product Code LWQ
  • Reason
    Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
  • Action
    Notification is being made by ATS Medical representatives hand delivery of notification letters dated February 18, 2004 to consignees. Representatives will identify and inspect inventory and return any defective product to ATS Medical. The letter will be signed and returned to verify notification.

Device

Device Recall ATS Mechanical Heart Valve
  • Model / Serial
    500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide throughout the US and worldwide.
  • Product Description
    ATS Open Pivot Mechanical Heart Valve
  • Manufacturer
    ATS Medical, Inc.

Manufacturer

ATS Medical, Inc.
  • Manufacturer Address
    ATS Medical, Inc., 3905 Annapolis Ln N Ste 105, Minneapolis MN 55447-5473
  • Source
    USFDA