Events

Recall of PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Culpan Medical 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-00865-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00865-1
  • 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
    It was identified that the phil container (syringe) may elute unintended elements (metals) into phil device formulation. this elution may discolour the phil device, or may not change the appearance of the device. at this point no adverse events related to product deficiency or specific patient reactions were reported to the manufacturer. microvention has not currently identified possible risk to patients associated with previous uses of phil devices. culpan medical is in negotiations with the tga regarding the need for any further actions.
  • Action
    Customers are advised to identify and quarantine all affected devices in their possession and return them to Culpan Medical. Recommended patient follow-up for doctors: continue to collect and report to the Therapeutic Goods Administration and the manufacturer any Adverse Events/Patient Reactions. This action has been closed-out on 10/05/2017.

Device

PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended fo...
  • Model / Serial
    PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)Product Codes: LEN10250, LEN10300, LEN10350All Batch Numbers affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Culpan Medical Pty Ltd

Manufacturer

Culpan Medical Pty Ltd