Events

Rappel de Device Recall HeartWare Ventricular Assist System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par HeartWare Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70340
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1131-2015
  • Date de mise en oeuvre de l'événement
    2015-01-16
  • Date de publication de l'événement
    2015-02-25
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133229
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Ventricular (assisst) bypass - Product Code DSQ
  • Cause
    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
  • Modèle / numéro de série
    Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    HeartWare Inc, 14400 Nw 60th Ave, Miami Lakes FL 33014-2807
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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