Events

Recall of Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Edwards Lifesciences 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-2013-RN-00675-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00675-1
  • 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
    During inspection of some distributed rigid suction wands (model s099), edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • Action
    Customers are asked to quarantine the affected product from inventory and return all affected stock with remaining shelf life to Edwards. Customers are asked to contact Edwards customer service or sales representative about alternative suction wand product's availability.

Device

Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid...
  • Model / Serial
    Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)Model code: S099All lot numbers ARTG number: 154578
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd