Events

Recall of Device Recall HVAD Pump Implant Kit

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
    64390
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2013
  • Event Initiated Date
    2012-12-27
  • Event Date Posted
    2013-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115985
  • 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 (assist) bypass - Product Code DSQ
  • Reason
    Heartware, inc. of miami lakes, fl is recalling their ventricular assist system due to the loosening of the hvad pump driveline connector.
  • Action
    HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.

Device

Device Recall HVAD Pump Implant Kit
  • Model / Serial
    Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
  • Product Description
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
  • Manufacturer
    Heartware Inc

Manufacturer

Heartware Inc
  • Manufacturer Address
    Heartware Inc, 14000 NW 57th Ct, Miami Lakes FL 33014-3105
  • 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