Events

Rappel de Device Recall Ventricular Assist Device

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
    65328
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1813-2013
  • Date de mise en oeuvre de l'événement
    2013-05-16
  • Date de publication de l'événement
    2013-07-29
  • 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=118566
  • 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
    Potential to electrostatic discharged (esd).
  • Action
    HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to quality@heartwareinc.com. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.

Device

Device Recall Ventricular Assist Device
  • Modèle / numéro de série
    US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
  • Description du dispositif
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
  • 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