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.

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
    76807
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1832-2017
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • 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=154236
  • 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
    In april 2015, heartware, now a part of medtronic, notified users of a safety issue related to the hvad pump driveline splice kit. medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
  • Action
    HeartWare, now a part of Medtronic sent an Urgent Medical Device Recall letter on April 2015 and a follow-up letter on March 2017, to customers via overnight mail and/or email.. The letters identified the affected product, problem and actions to be taken. Customers were instructed to review the recall notice, forward the notice to individuals within their organization who need to be aware of the notice, complete, sign, and return the Acknowledgement Form . For questions contact your local HeartWare representative.

Device

Device Recall Heartware Ventricular Assist System
  • Modèle / numéro de série
    Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
  • Description du dispositif
    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

Manufacturer

Heartware
  • Adresse du fabricant
    Heartware, 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