Events

Recall of Zenith Alpha Thoracic Endovascular Graft

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

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
    RC-2017-RN-00824-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00824-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Cook medical previously advised customers in march 2017 (rc-2017-rn-00419-1) about an update to the instructions for use (ifu) for the zenith alpha thoracic endovascular graft.Since then, cook medical has received additional complaints for the same issue. although the complaints were from patients treated prior to the march notification, there is now an additional correction of the (ifu) and the removal of specific sizes from the market.The correction to the ifu removes the indication for use in blunt thoracic aortic injury (btai), and a warning has been added to describe the thrombus risk that has been observed when the device is used to treat btai. patients already treated with this product for the btai indication should be followed up according to the current ifu, with considerations outlined in cook medical’s correspondence in march 2017.Potential adverse events that may occur if these devices were used for btai include death, paraplegia, and/or surgical intervention.
  • Action
    Cook Medical is requesting that Customers: 1. Share this notice with others in their organisation who either use this device or follow patients treated with this device. 2. Follow the IFU corrections as provided. 3. Examine inventory and immediately quarantine affected products. 4. Complete and return the required Acknowledgement and Receipt Form, in addition to any affected recalled products to Cook Medical. Return Goods Authorisation Number: QCR-75 Cook Medical 61 Brandl Street Eight Mile Plains QLD 4113 5. Maintain a copy of this notice for their records. Upon availability of the corrected IFU, a Cook Medical Sales Representative will personally follow-up and provide corrected IFUs for inventory.

Device

Zenith Alpha Thoracic Endovascular Graft
  • Model / Serial
    Zenith Alpha Thoracic Endovascular GraftCatalogue Numbers: ZTA-D-/-ZTA-DE-/-ZTA-P-/-ZTA-PT-/- Multiple Catalogue Identifier and Global Product NumbersAll LotsARTG Numbers: 222505, 222526, 222533, 222525
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd