Events

Rappel de Device Recall Terumo Coronary Ostia Cannulae

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 Terumo Cardiovascular Systems 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
    58762
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2556-2011
  • Date de mise en oeuvre de l'événement
    2011-05-16
  • Date de publication de l'événement
    2011-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100268
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. the plastic skiving may detach and enter the patient, embolizing the coronary vasculature. the potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedu.
  • Action
    Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.

Device

Device Recall Terumo Coronary Ostia Cannulae
  • Modèle / numéro de série
    Part Number 804159 lot 0520498, 0528975, 0567050, 0582503, 0617088, 0624866.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Description du dispositif
    804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA