Events

Recall of RIGID TIP SUCTION WAND

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
    18094
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-06
  • 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
    This recall activity is restricted to corrective action regarding the standard tip suction wand. due to an insufficient adhesive application the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity during surgery. this would likely be identified during or prior to the procedure.

Device

RIGID TIP SUCTION WAND
  • Model / Serial
    Model Catalog: SU-12202 (Lot serial: S111480)
  • Product Description
    STANDARD RIGID TIP SUCTION WAND
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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