Events

Recall of ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical Specialties 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-00091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00091-1
  • 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
    The manufacturer (isomed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (av) fistulas, the catheter used should have the tensile strength to withstand at least 9n of resistance. after extensive testing, it was determined that the maximum resistances of the isomed 2f, 3f & 4f single lumen arterial embolectomy catheters are: 3n, 5n & 9n respectively. to minimise the risk of vessel damage, balloon rupture or tip detachment in av fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4f (i.E. 2f & 3f) should not be used for these procedures. the “warnings” section of the ifu has been updated to include this information.
  • Action
    Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017.

Device

ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)
  • Model / Serial
    ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)Product/Catalogue Numbers (2F): 300240, 300260, 300280, 300240T, 300260T, 300280TProduct/Catalogue Numbers (3F): 300340, 300360, 300380, 300340T, 300360T, 300380TAll Lots/Batches affectedARTG Number: 168959
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA