Events

Recall of Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Sorin Group Australia.

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-2014-RN-00032-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00032-1
  • 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
    For the size and lots identified, the blue marker (placed on the catheter shaft close to the balloon proximal extremity, aiding correct positioning of the balloon with respect to the prosthesis, prior to dilation) may detach and displace during removal of the plastic tube which protects the balloon. removal of the plastic tube protection may displace the blue marker distal to the balloon. if this is not identified, the blue marker might then fall in the operative field, including the possibility to fall in the patient ventricle during the post-dilation procedure, causing serious injury or death if it is not retrieved.
  • Action
    Sorin is recommending that clinicians follow the indications provided in the customer letter to remove the plastic tube protecting the balloon and to verify that the blue marker is not displaced. In case the verification leads to the conclusion that the marker is displaced, the involved post-dilation catheter must not be used and must be replaced with a new one.

Device

Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve ...
  • Model / Serial
    Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)Item number: ICV1149Lot numbers: 1306130204, 1306170173 1307290152, 1309230205ARTG Number: 204444
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia