Events

Safety Alert for HeartMate II and HeartWare HVAD

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Thoratec.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-08-06
  • Event Date Posted
    2015-08-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150806.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: implantable left ventricular assist devices the united states food and drug administration (fda) has issued a medical device safety alert concerning two implantable left ventricular assist devices (lvads). the affected devices are as follow:- fda is alerting health care providers, patients, and caregivers about serious adverse events associated with lvads. these adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with thoratec’s heartmate ii and a high rate of stroke with the heartware hvad since approval of the devices. fda is also aware of bleeding complications related to both the thoratec heartmate ii and heartware hvad. when used for the currently approved indications in appropriately selected patients, fda believes the benefits of these lvads continue to outweigh the risks. however, the fda also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients. for details, please refer to the fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm457333.Htm http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm457327.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 august 2015.

Device

HeartMate II and HeartWare HVAD
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Implantable Left Ventricular Assist Devices
  • Manufacturer
    Thoratec

Manufacturer

Thoratec
  • 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
    DH