Events

Recall of SARNS 9000 PERFUSION SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO CARDIOVASCULAR SYSTEMS CORP..

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
    31939
  • Event Risk Class
    II
  • Event Initiated Date
    2001-01-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Prior to the onset of cardiopulmonary bypass while the pump circuit was being primed the roller pump suddenly began to rotate at its maximum rate. the pump was turned off and replaced with a new one.

Device

SARNS 9000 PERFUSION SYSTEM

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS CORP.
  • Manufacturer Address
    ANN ARBOR
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC