Events

Recall of Device Recall AB5000 Portable Driver

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
    52168
  • Event Risk Class
    Class 2
  • Event Number
    Z-1914-2009
  • Event Initiated Date
    2009-05-08
  • Event Date Posted
    2009-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82368
  • 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
    The emergency system operation (eso) mode may not provide adequate patient support under a specific operating condition.
  • Action
    Abiomed notified customers via an Urgent - Voluntary Medical Device Field Removal Notice on May 8, 2009 advising users that the Emergency System Operation (ESO) mode may not provide adequate patient support under a specific operating condition. The letter stated that customers may continue to support patients with the AB Portable Driver during the process since the failure has not occurred during patient support. An Abiomed Field Service Engineer will contact customers and arrange for a temporary exchange for the affected driver with a corrected driver. The firm recommends that customers switch the patient to hand pump support and switch patient to backup driver until they can confirm that the Driver(s) has been corrected by an Abiomed Field Service. Questions are to be directed to Michael O'Hara at 978-646-1543 or a Field Service at 800-554-8666.

Device

Device Recall AB5000 Portable Driver
  • Model / Serial
    Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
  • Product Description
    Abiomed AB5000 Portable Driver || Catalog number: 0025-0000 || The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
  • 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