Events

Recall of HEARTSTRING II PROXIMAL SEAL SYSTEM

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
    23649
  • Event Risk Class
    I
  • Event Initiated Date
    2009-02-11
  • 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
    During a routine shelf-life aging test a number of devices exhibited signs of damaged packaging which may lead to compromised sterility which has 30% chance of death as the contamination is on the bloodstream.

Device

HEARTSTRING II PROXIMAL SEAL SYSTEM
  • Model / Serial
    Model Catalog: HSK-2043 (Lot serial: 8030571 TO 9011671); Model Catalog: HSK-2038 (Lot serial: 8030372 TO 9012271); Model Catalog: HSK-2043 (Lot serial: 8030372 TO 9012271); Model Catalog: HSK-2038 (Lot serial: 8030571 TO 9011671)
  • Product Description
    HEARTSTRING II PROXIMAL SEAL SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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