Events

Recall of Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Merit Medical 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-01511-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01511-1
  • 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
    Merit medical systems, inc. is conducting a recall of specific lots of prelude snap splittable sheath introducers due to an intermittent failure of the splittable hub. merit medical has received complaints indicating that the wings on certain lots of the prelude snap have broken off the sheath hub during splitting. this will likely result in a minor delay in procedure. although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. merit has received no reports of patient harm or injury as a result of this issue.
  • Action
    Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit Medical.

Device

Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit
  • Model / Serial
    Prelude SNAP Splittable Sheath IntroducerVascular Introducer KitMultiple Catalogue and Lot Numbers AffectedARTG 278434
  • Manufacturer
    Merit Medical Australia Pty Ltd

Manufacturer

Merit Medical Australia Pty Ltd