Events

Recall of Device Recall Atrium

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atrium 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
    76138
  • Event Risk Class
    Class 2
  • Event Number
    Z-1222-2017
  • Event Initiated Date
    2017-01-20
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152289
  • 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
    Catheter, cholangiography - Product Code GBZ
  • Reason
    Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 fr and 10 fr thoracic catheters is two (2).
  • Action
    Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).

Device

Device Recall Atrium
  • Model / Serial
    All Lot Numbers With Expiration Date Prior To December 2019
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Atrium PVC 10 Fr Straight Thoracic Catheter || Code Number: 8010
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA