Events

Rappel de iPulse Circulatory Support 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 Abiomed, 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
    52200
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1931-2009
  • Date de mise en oeuvre de l'événement
    2009-04-23
  • Date de publication de l'événement
    2009-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82493
  • 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 Support System - Product Code DSQ
  • Cause
    Ipulse console sc1035 displayed a "low pressure / low flow" alarm and stopped pumping during patient transport in battery operation.
  • Action
    An "Urgent Voluntary Medical Device Field Correction Notice" was issued April 8, 2009 to affected customers. The customers were notified that the iPulse Console SC1032 displayed a "Low Pressure/ Low Flow" alarm and stopped pumping during patient transport in battery operation. Instructions were provided to users in case they encounter this failure mode. ABIOMED Field Service Engineers will contact customers to schedule a time to visit site and correct affected consoles. Please contact ABIOMED's Field Service at 1.800.554.8666, if you have any questions.

Device

iPulse Circulatory Support System
  • Modèle / numéro de série
    Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Domestic: MA, MI, SC, NY, NJ, OH, CA, PA, AR, MI, MD, CT, IL, WI, TX, NJ, TN, IN, MI, DE, FL, IA, WA, KY, and WV Foreign: Germany, Greece, Italy, Latvia, Spain, and Turkey
  • Description du dispositif
    iPulse Circulatory Support System || Catalog number: 0036-0010 || The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.
  • Manufacturer
    Abiomed, Inc.

Manufacturer

Abiomed, Inc.
  • Adresse du fabricant
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923
  • Société-mère du fabricant (2017)
    Abiomed, Inc.
  • Source
    USFDA