Events

Recall of Twin-Pass dual access catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pyramed 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-2016-RN-01234-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01234-1
  • 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
    An investigation of twin-pass units has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or inside the distal part of the rapid exchange lumen of twin-pass dual access catheters. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of an embolism to the patient. there have been no reports of injuries associated with this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Pyramed has advised users to quarantine and return the affected devices. This action has been closed-out on 11/11/2016.

Device

Twin-Pass dual access catheters
  • Model / Serial
    Twin-Pass dual access cathetersModel Number: 5200Multiple lot numbers affectedSupplied through the Special Access Scheme (SAS)
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd