Events

Recall of VASCUTEK GELWEAVE VASCULAR PROSTHESIS - STRAIGHT

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
    53873
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-23
  • 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
    Vascutek is providing important user information regarding gelweave vascular prosthesis. currently vascutek provides a high temperature cautery with each gelweave vascular graft. vascutek have decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the graft.

Device

VASCUTEK GELWEAVE VASCULAR PROSTHESIS - STRAIGHT
  • Model / Serial
    Model Catalog: 731224 (Lot serial: ALL LOTS); Model Catalog: 731222 (Lot serial: ALL LOTS); Model Catalog: 731220 (Lot serial: ALL LOTS); Model Catalog: 731218 (Lot serial: ALL LOTS); Model Catalog: 731034 (Lot serial: ALL LOTS); Model Catalog: 731032 (Lot serial: ALL LOTS); Model Catalog: 731030 (Lot serial: ALL LOTS); Model Catalog: 736038 (Lot serial: ALL LOTS); Model Catalog: 736034 (Lot serial: ALL LOTS); Model Catalog: 736032 (Lot serial: ALL LOTS); Model Catalog: 736030 (Lot serial: ALL LOTS); Model Catalog: 736028 (Lot serial: ALL LOTS); Model Catalog: 736026 (Lot serial: ALL LOTS); Model Catalog: 736024 (Lot serial: ALL LOTS); Model Catalog: 736022 (Lot serial: ALL LOTS); Model Catalog: 736016 (Lot serial: ALL LOTS); Model Catalog: 736014 (Lot serial: ALL LOTS); Model Catalog: 736010 (Lot serial: ALL LOTS); Model Catalog: 736008 (Lot serial: ALL LOTS); Model Catalog: 736006 (Lot serial: ALL LOTS); Model Catalog: 735034ST (Lot serial: ALL LOTS); Model Catalog: 735034 (Lot serial: ALL LOTS); Model Cat
  • Product Description
    GELWEAVE STRAIGHT
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

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