Events

Safety Alert for HeartWare Ventricular Assist System Pump Driveline Splice Kit

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
    2015-05-21
  • Event Date Posted
    2015-05-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150521.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 pump driveline splice kit the united states food and drug administration (fda) has issued a medical device safety alert concerning heartware ventricular assist system (hvad) pump driveline splice kit. the affected devices are identified as follow:- model: 1) hvad pump driveline splice kit; 2) hvad pump driveline splicekit; large od sheath catalogue numbers: 1) asy00116; 2) asy00281 lot numbers: 1) 532770, 567949, 480786, 483769, 490692, 539664, 598189; 2) 654090, 672401, 678800, 690423, 833963, 873159, 880816 according to the manufacturer, excessive force applied will cause failures of the splice repair kit. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1604-2015&w=05202015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 may 2015.

Device

HeartWare Ventricular Assist System Pump Driveline Splice Kit
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: HeartWare Ventricular Assist System Pump Driveline Splice Kit
  • 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