Events

Recall of ACROBAT V VACUUM STABLIZER

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
    149115
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-19
  • 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
    An internal finding identified the presence of pinholes/cuts in some of the tyvek pouches of the vacuum tubing sets included as an accessory to these products. as a result there is a potential for the pouch integrity to be compromised which may result in compromised sterility of the product. if the compromised product is used in surgery there is a potential risk of infection for the patient.

Device

ACROBAT V VACUUM STABLIZER
  • Model / Serial
    Model Catalog: OM-9100S (Lot serial: 25097068); Model Catalog: OM-9100S (Lot serial: 25095207); Model Catalog: OM-9100S (Lot serial: 25092968); Model Catalog: OM-9100S (Lot serial: 25091907); Model Catalog: OM-9100S (Lot serial: 25089063); Model Catalog: OM-9100S (Lot serial: 25084722); Model Catalog: OM-9100S (Lot serial: 25081832); Model Catalog: OM-9100S (Lot serial: 25097679); Model Catalog: OM-9100S (Lot serial: 25092783)
  • Product Description
    ACROBAT V Vacuum Off-Pump System
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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