Events

Recall of HeartWare

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
    71099
  • Event Risk Class
    Class 1
  • Event Number
    Z-1604-2015
  • Event Initiated Date
    2015-04-29
  • Event Date Posted
    2015-05-14
  • 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=136083
  • 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
    Failures of the splice repair kit if exposed to excessive force.
  • Action
    HeartWare, Inc. sent an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015. The letter identified the affected product, problem, and actions to be taken by the consignees. The firm requested that consignees: 1) review the notice and the Patient Communication contents, 2) forward the notice to individuals within their organization who need to be aware of the notice, 3) identify patients that are currently on support and have undergone a driveline splice repair, 4) distribute the Patient Communication to the affected patients in person, 5) continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments, 6) complete, sign, and return the "Acknowledge and Completion Form to HeartWare within 30 days of receipt of the letter. Should any questions or concerns arise, please contact there local HeartWare representative. Their 24-hour Clinical Support personnel are also available at 1 (888) 494-6365.

Device

HeartWare
  • Model / Serial
    Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
  • Product Description
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit || Product Usage: || Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
  • 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