Events

Recall of CURVED TIP WIRE-REINFORCED 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
    27386
  • Event Risk Class
    I
  • Event Initiated Date
    2017-06-26
  • 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 inspection of product in its inventory sorin has identified that plastic flash may be present on the tip of the aortic arch cannulae. there is a risk that flash can become detached during cardiac surgery and be released into the patient's blood circulation resulting in the possibility of embolism. to mitigate this hazard sorin is removing these affected aortic arch cannulae from the marketplace and replacing them with new aortic cannulae which have been verified not to contain flash.

Device

CURVED TIP WIRE-REINFORCED AORTIC ARCH CANNULA
  • Model / Serial
    Model Catalog: RA-1137 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: NA-1337 (Lot serial: 1700300233); Model Catalog: NA-001TG (Lot serial: 1519500072); Model Catalog: NA-1337 (Lot serial: 1617900116); Model Catalog: NA-1337 (Lot serial: 1611700045); Model Catalog: NA-1337 (Lot serial: 1608800130); Model Catalog: NA-1337 (Lot serial: 1607500029); Model Catalog: NA-1337 (Lot serial: 1530000132); Model Catalog: NA-1337 (Lot serial: 1528600115); Model Catalog: NA-001TG (Lot serial: 1701600204); Model Catalog: NA-001TG (Lot serial: 1634000158); Model Catalog: NA-001TG (Lot serial: 1629800189); Model Catalog: NA-001TG (Lot serial: 1627100070); Model Catalog: NA-001TG (Lot serial: 1623600028); Model Catalog: NA-001TG (Lot serial: 1611700043); Model Catalog: NA-001TG (Lot serial: 1528600113); Model Catalog: NA-1337 (Lot serial: 1620000013)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    AORTIC ARCH CANNULAE RA-1137;AORTIC ARCH CANNULAE NA-1337;AORTIC ARCH CANNULAE NA-001TG
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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