Events

Safety Alert for HeartWare Ventricular Assist System

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

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
    2015-06-17
  • Event Date Posted
    2015-06-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150617.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: heartware ventricular assist system the united states food and drug administration (fda) has issued medical device safety alerts concerning heartware ventricular assist system (vas), manufactured by heartware. the affected devices are identified as follow:- product codes: 1101, 1103 serial numbers: all heartware systems currently in use manufacturing and distribution dates: january 2008 to march 2015 the alignment guides in the power supply connector ports may wear down over time. this can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their vas. an interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. the company has reported 33 reports of malfunction and one serious injury related to this problem. the manufacturer sent their customers an urgent medical device correction notice on may 25, 2015 to alert them of the problem and actions to take. the manufacturer will replace all defective controllers by the end of june 2016. the manufacturer is reminding patients to use the device safely: never disconnect from both power sources at the same time. take care when connecting to power sources. keep the outer sheath of the driveline protected from excessive sunlight. beware of accidental snagging or pulling of the driveline. according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm451456.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451447.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2015.

Device

HeartWare Ventricular Assist System
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: HeartWare Ventricular Assist System
  • Manufacturer
    HeartWare

Manufacturer

HeartWare
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH