Events

Recall of Device Recall Impella 5.0 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
    56315
  • Event Risk Class
    Class 2
  • Event Number
    Z-2382-2010
  • Event Initiated Date
    2010-07-05
  • Event Date Posted
    2010-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93206
  • 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
    pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Reason
    Pump may separate at the motor housing while device is explanted.
  • Action
    ABIOMED issued the recall notification letter on July 5 , 2010 to the one affected customer (France) and requested that they segregate and return any unused pumps. The pumps in Canada were already used. If you have any questions, contact +49 241 8860-0 or e-mail europe@abiomed.com.

Device

Device Recall Impella 5.0 Circulatory Support System
  • Model / Serial
    Serial numbers: 45921,45922,45923,45924
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International only: Canada and France
  • Product Description
    Impella 5.0 Circulatory Support System || Catalog number: 004840 || The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
  • 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