Events

Recall of INTEGRAL ANGLED TIP FLEXIBLE AORTIC ARCH CANNULA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA 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
    20402
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-14
  • 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
    Sorin group usa has become aware of some aortic arch cannulae (part numbers na-55x7 and na-55x8 specific lot range) distributed in the market where the angle of the distal end may be less than specified. the cannulae consist of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. the defective cannulae are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

Device

INTEGRAL ANGLED TIP FLEXIBLE AORTIC ARCH CANNULA
  • Model / Serial
    Model Catalog: NA-5538 (Lot serial: 1602600042); Model Catalog: NA-5536 (Lot serial: 1602600042); Model Catalog: NA-5537 (Lot serial: 1520100050); Model Catalog: NA-5537 (Lot serial: 1602600042); Model Catalog: NA-5536 (Lot serial: 1529300028); Model Catalog: NA-5538 (Lot serial: 1529300028); Model Catalog: NA-5537 (Lot serial: 1529300028); Model Catalog: NA-5536 (Lot serial: 1520100050); Model Catalog: NA-5538 (Lot serial: 1520100050)
  • Product Description
    AORTIC ARCH CANNULAE
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC