Events

Recall of HeartWare Ventricular Assist System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HeartWare, Inc.

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
    74999
  • Event Risk Class
    Class 1
  • Event Number
    Z-0006-2017
  • Event Initiated Date
    2016-08-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149075
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventricular (assisst) bypass - Product Code DSQ
  • Reason
    Foreign material found within the driveline connector of the hvad pump that could cause increased impedance resulting in electrical faults.
  • Action
    HeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104. The letter discussed the reason for the recall as well as the risk to health. Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form. Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665. Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned. Questions or concerns should be directed to a local HeartWare representative.

Device

HeartWare Ventricular Assist System
  • Model / Serial
    All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
  • Product Description
    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. || Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
  • Manufacturer
    HeartWare, Inc

Manufacturer

HeartWare, Inc
  • Manufacturer Address
    HeartWare, Inc, 14400 NW 60th Ave, Miami Lakes FL 33014-2807
  • 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
    USFDA