Events

Recall of MEGA 8FR. INTRA-AORTIC BALLOON CATHETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    93339
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-11
  • 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
    It was discovered during post-quarantine packaging on february 16 2016 that the ifu for the statlock sheath stabilization device for percutaneous sheath introducers (incorrect ifu) was erroneously packaged with the mega and sensation plus iab catheter kits instead of the ifu for the statlock catheter stabilization device for iab catheters (correct ifu).

Device

MEGA 8FR. INTRA-AORTIC BALLOON CATHETER
  • Model / Serial
    Model Catalog: 0684-00-0296-01 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC