Events

Rappel de Device Recall EKOS EkoSonic Endovascular 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 EKOS Corporation.

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
    73195
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0864-2016
  • Date de mise en oeuvre de l'événement
    2016-01-21
  • Date de publication de l'événement
    2016-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143565
  • 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
    Catheter, continuous flush - Product Code KRA
  • Cause
    The ekosonic kit, including the individually labeled microsonic device (msd) and intelligent drug delivery catheter (iddc) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the msd actual working length is 106 cm.
  • Action
    All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT  VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 Jocelyn.kersten@ekoscorp.com

Device

Device Recall EKOS EkoSonic Endovascular Device
  • Modèle / numéro de série
    Lot Number 150910004. Expiration date is August 15, 2018.  Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of AZ, CA, MA, MI, OH, and VA.
  • Description du dispositif
    EkoSonic Endovascular System, Catalog Number 500-56112. || It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface || Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Adresse du fabricant
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    USFDA