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
    27071
  • Event Risk Class
    Class 2
  • Event Number
    Z-1222-03
  • Event Initiated Date
    2003-08-19
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29128
  • 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 (Assist) Bypass - Product Code DSQ
  • Reason
    Bi-ventricular support system may switch to battery when primary voltage (ac) is available.
  • Action
    Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.

Device

Device Recall Abiomed
  • Model / Serial
    Serial Numbers: 3042, 3045-3047, 3049-3080.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide. CA, DE, IL, IN, KY, FL, LA, MD, ND, NJ, NY, OR, WI, TX
  • Product Description
    BVS 5000t Bi-Ventricular Support System Transport/Backup Console || Catalog Number: 0050-000
  • Manufacturer
    Abiomed, Inc.

Manufacturer

Abiomed, Inc.
  • Manufacturer Address
    Abiomed, Inc., 22 Cherry Hill Drive, Danvers MA 01923
  • Source
    USFDA