Events

Recall of Device Recall Ventricular Assist Device

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
    73636
  • Event Risk Class
    Class 1
  • Event Number
    Z-1887-2016
  • Event Initiated Date
    2016-01-07
  • 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=144646
  • 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 ventricular assist system battery cell experiencing premature depletion.
  • Action
    The firm, HeartWare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 7, 2016, to all their consignees informing them that of the HeartWare¿ HVAD Battery recall (device exchange). The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Promptly complete the attached Acknowledgment Form and return it to HeartWare no later than 30 days from the date of this letter via email to HeartWare7786@stericycle.com or provide verbal Acknowledgement by calling Customer Service line , 1(844)491-7871; or fax to +1 (844)721-3044.. 2. Immediately identify and quarantine affected batteries in hospital inventory, and apply a RECALLED PRODUCT  DO NOT USE sticker (provided with this notice) as illustrated below. Replace quarantined inventory AC Adapters and batteries by requesting a Return Goods Authorization (RGA) through a qualified representative or directly through HeartWare Customer Service (via telephone 1-877-367-4823 or email cs@heartware.com). A qualified representative will update the Controller software for affected Controller units in inventory. 3. Identify, collect and quarantine affected product in patient possession. Arrange for current patients to bring their Batteries to a clinic appointment as soon as possible, (at least within the next three months), with urgency dependent upon individual patient circumstances. During their regularly scheduled appointment, a qualified representative will assist with quarantining and replacing affected product. Apply a RECALLED PRODUCT  DO NOT USE sticker as illustrated on affected batteries. Replace affected patient product using hospital inventory, and replace consumed hospital inventory by requesting an RGA as described above. 4. Return affected product to HeartWare. Your HeartWare representative will assist you with returning affected product to HeartWare. 5. Complete and return the attached Completion Form no later than 6 months from the date of this let

Device

Device Recall Ventricular Assist Device
  • Model / Serial
    Serial numbers ranging BAT000001 to BAT199999.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.
  • Product Description
    HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) || Product Usage: || Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-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