Events

Recall of Device Recall 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
    70340
  • Event Risk Class
    Class 1
  • Event Number
    Z-1131-2015
  • Event Initiated Date
    2015-01-16
  • Event Date Posted
    2015-02-25
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133229
  • 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
    The affected clinical trial controllers exhibit a higher susceptibility to esd than newer commercial controllers.
  • Action
    HeartWare sent an URGENT MEDICAL DEVICE RECALL dated January 16, 2015 asking clinicians to quarantine the affected controllers and complete and return the acknowledgement form. HeartWare also asks clinicians to identify patients with affected controllers and review the applicable risks with the patient and as soon as reasonably possible if medically advisable, exchange the affected controller under medical supervision with a new controller. HeartWare also asks that for each patient using an affected controller as their backup to contact the patient and arrange to have the backup controller replaced with a new controller. Lastly, HeartWare asks the firm to complete the patient tracking form and return all quarantined controllers to HeartWare along with the completion form. Should you have any questions or concerns, please contact your local HeartWare representative. Our 24-Hour Clinical Support personnel are also available at 1-888-494-6365.

Device

Device Recall HeartWare Ventricular Assist System
  • Model / Serial
    Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
  • Product Description
    HeartWare Ventricular Assist System (HeartWare Controller) || 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. The HeartWare System is 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