Events

Rappel de 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
    74999
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0006-2017
  • Date de mise en oeuvre de l'événement
    2016-08-17
  • Statut de l'événement
    Open, Classified
  • 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=149075
  • 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
    Foreign material found within the driveline connector of the hvad pump that could cause increased impedance resulting in electrical faults.
  • Action
    HeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104. The letter discussed the reason for the recall as well as the risk to health. Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form. Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665. Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned. Questions or concerns should be directed to a local HeartWare representative.

Device

HeartWare Ventricular Assist System
  • Modèle / numéro de série
    All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
  • Description du dispositif
    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. || 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. 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