Events

Recall of HeartMate II System Controller; component of the HeartMate II Left Ventricular Device System (LVAS)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thoratec Corp.

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
    56694
  • Event Risk Class
    Class 2
  • Event Number
    Z-0058-2011
  • Event Initiated Date
    2010-09-01
  • Event Date Posted
    2010-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94299
  • 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
    Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection.
  • Action
    Thoratec Corporation sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 30, 2010, to all customers. The letter described the affected product, description and symptoms of problem, and immediate action to be taken by the customers. The customers were instructed to: 1) contact all ongoing patients using the affected Systems Controllers (serial numbers starting with "EPC") to determine if they are experiencing any unexplained intermittent alarms or have any bent pins in the connectors between the System Controller and the power sources, if so, have them return to the hospital so that their power leads can be examined. If further assistance is needed with the evaluation, please contact Thoratec Technical Service (800-456-1477). 2) review the attached addendum to the HeartMate II labeling with all VAD clinicians and ongoing HeartMate II LVAS patients, and 3) complete and sign the attached Acknowledgment Form via fax to Thoratec Regulatory Affairs at (952) 847-8571. If you have any questions, please contact 925-847-8600.

Device

HeartMate II System Controller; component of the HeartMate II Left Ventricular Device System (LVAS)
  • Model / Serial
    All serial numbers starting with EPC prefix
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX , UT, VA, WA, and WI; and countries including: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Netherlands, Singapore, Slovenia, Sweden, Switzerland, and the UK.
  • Product Description
    HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA || The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular
  • Manufacturer
    Thoratec Corp

Manufacturer

Thoratec Corp
  • Manufacturer Address
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA