Events

Recall of HeartMate 3 Left Ventricular Assist System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott 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-2018-RN-00668-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-06-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00668-1
  • 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
    Further to the april 2018 safety alert communication (rc-2018-rn-00302-1) sent to surgeons in regards to heartmate 3 (hm3) outflow graft twist occlusions, abbott have identified the need for further clarification on the origin of the outflow graft twist, the persistent low flow alarm, additional recommendations for patient management and future mitigations to be implemented. abbott is aware that accumulation of an outflow graft twist may occur at any point post-implantation, which can reduce or stop pump flow. occlusion of the hm3 outflow graft often requires urgent surgical intervention.
  • Action
    Abbott is advising they are investigating mitigations to prevent Outflow Graft twist occlusion. In the interim, Abbott recommends the following for HM3 patients: Existing Patients: - Surgeons should refer to the information provided in the Customer Letter for managing patients who have been implanted with HM3 New Patients: - During implant, when attaching the Outflow Graft to the Pump Cover, a clicking sound will be heard as the Screw Ring is tightened. Continue turning the Screw Ring clockwise until it comes to a complete stop and stops clicking. Firmly hand-tightening the Screw Ring may reduce the risk of Outflow Graft twisting by increasing the resistance to metallic Outflow Graft connector rotation. To avoid damaging the Outflow Graft assembly, do not use tools to tighten the screw ring. - The proposed clarification on Warning and additional Caution statement will be incorporated into the Instructions for Use

Device

HeartMate 3 Left Ventricular Assist System
  • Model / Serial
    HeartMate 3 Left Ventricular Assist System Catalogue Number: 106524INT LVAS KIT, HM3 ARTG Number: 300895(Abbott Medical Australia - HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system)
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Abbott Medical Australia Pty Ltd

Manufacturer

Abbott Medical Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA