Events

Rappel de Device Recall EKOS EkoSonic Endovascular 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 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
    71635
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2148-2015
  • Date de mise en oeuvre de l'événement
    2015-06-24
  • Date de publication de l'événement
    2015-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138434
  • 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 connector interface cable (cic) was not recognized by the ekosonic pt-3b control unit.
  • Action
    Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.

Device

Device Recall EKOS EkoSonic Endovascular System
  • Modèle / numéro de série
    CIC Serial Numbers:  19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103,  19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112,  19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118,  19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127,  19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135,  19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144,  19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153,  19598-154, 19598-156, 19598-157, 19598-158.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. || The EkoSonic Endovascular System 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, nonsterile 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