Events

Recall of Device Recall Circulatory Support System

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
    54167
  • Event Risk Class
    Class 1
  • Event Number
    Z-0824-2010
  • Event Initiated Date
    2009-12-16
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87750
  • 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
    Ventricular (assisst) bypass - Product Code DSQ
  • Reason
    Console shut down with no audible alarm.
  • Action
    Abiomed initiated the recall by telephone contact and followed with a Recall Letter dated January 27, 2010. Consignees were informed that a Field Service Engineer will be in contact and schedule a time to visit and correct the affected device. For further information, contact Abiomed Quality Assurance at 1-978-656-1543 or Abiomed Field Service at 1-800-554-8666.

Device

Device Recall Circulatory Support System
  • Model / Serial
    Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
  • Product Description
    Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. || Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
  • Manufacturer
    Abiomed, Inc.

Manufacturer

Abiomed, Inc.
  • Manufacturer Address
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923
  • Manufacturer Parent Company (2017)
    Abiomed, Inc.
  • Source
    USFDA