Events

Recall of Maquet Heart Lung Machine HL20

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular Us Sales, Llc.

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
    57082
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-2011
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95340
  • 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
    Heart Lung Machine - Product Code DTQ
  • Reason
    A wrong ball bearing was installed in the pump heads of product. this may make the pump head wear out and cease function.
  • Action
    Maquet hand delivered a letter to the consignee on 10/4/2010.

Device

Maquet Heart Lung Machine HL20
  • Model / Serial
    Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One hospital in New York City
  • Product Description
    Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA