Events

Recall of ADVANCED PERFUSION SYSTEM 1 - BASE UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RYAN MEDICAL DISTRIBUTORS 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
    55469
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-30
  • 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
    Terumo cvs initially received nine reports of malfunction of the abd module or the occluder module for the terumo advanced perfusion system 1. its investigation found a faulty component on the modules application board had caused the failures. terumo cvs replaced all modules in the affected population. terumo cvs has subsequently received two additional reports of similar malfunctions. the ensuing investigation concluded that though highly unlikely it is possible for the same component to fail in any module.

Device

ADVANCED PERFUSION SYSTEM 1 - BASE UNIT
  • Model / Serial
    Model Catalog: 801763 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    Terumo Advanced Perfusion System 1 - Base Unit
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.