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
    71164
  • Event Risk Class
    Class 1
  • Event Number
    Z-1698-2015
  • Event Initiated Date
    2015-04-29
  • Event Date Posted
    2015-06-08
  • 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=136311
  • 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
    Heartware has received complaints relating to damage or bent connection pins within the power supply ports of the vad controller.
  • Action
    HeartWare sent an Urgent Medical Device Correction letter to customers on May 25, 2015. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Review the enclosed notice and Patient Communication. 2. Forward the notice to those individuals within their organization who need to be aware of its contents. 3. Identify the patients currently supported by the HVAD System. 4. Distribute the "Patient Communication" to their patients directly via FedEx or some other reliable means of communication. 5. Continue to reinforce the messages set forth in the notice with their patients during their regularly scheduled appointments. 6. Complete, sign and return the Acknowledgement and Completion Form to HeartWare within 30 days of receipt of this letter. For questions contact your local HeartWare representative or the 24-Hour Clinical Support personnel at 1-888-494-6365.

Device

HeartWare Ventricular Assist System
  • Model / Serial
    Serial #: ALL HeartWare HVAD systems currently in use.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
  • Product Description
    HeartWare Ventricular Assist System (HVAD). || Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. || Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
  • 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