Events

Recall of Device Recall Abiomed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abiomed, 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
    37170
  • Event Risk Class
    Class 2
  • Event Number
    Z-0574-2007
  • Event Initiated Date
    2007-01-08
  • Event Date Posted
    2007-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50038
  • 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
    Circulatory Support System - Product Code DSQ
  • Reason
    Unit may alarm ''low flow'' and ''low pressure'' due to manufacturing material in the pressure source.
  • Action
    Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.

Device

Device Recall Abiomed
  • Model / Serial
    Serial Numbers: 5261- 5317
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Japan, Germany, Australia, and Mexico.
  • Product Description
    AB5000 Console Circulatory Support System || Catalog Number: 0015-0000
  • Manufacturer
    Abiomed, Inc.

Manufacturer

Abiomed, Inc.
  • Manufacturer Address
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923-2575
  • Source
    USFDA