Events

Rappel de Device Recall Diamondback 360 Coronary Orbital Atherectomy 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 Cardiovascular Systems, 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
    67445
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1095-2014
  • Date de mise en oeuvre de l'événement
    2014-01-27
  • Date de publication de l'événement
    2014-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125479
  • 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, coronary, atherectomy - Product Code MCX
  • Cause
    Cardio vascular systems inc. has initiated a recall to request the immediate removal and return of diamondback 360 coronary orbital atherectomy device (oad). the device mistakenly contains a saline line that is used in our peripheral atherectomy device. this saline line was not part of the fda approval for use in the coronary device. it therefore does not meet specification for this device. c.
  • Action
    Cardiovascular Systems Inc. sent an "Urgent Medical Device Recall" letter dated January 27, 2014 to all affected customers. The letter described the affected product, recall description and actions to be taken. Customers were instructed to complete and return the attached Customer Acknowledgement Form and return the device i available. For further information they should contact CSI Customer Service at 651 Campus Drive, Saint Paul, MN 55112, Tele 877-274-0901, Fax 612-677-3355.

Device

Device Recall Diamondback 360 Coronary Orbital Atherectomy System
  • Modèle / numéro de série
    Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
  • Description du dispositif
    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 || Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • Adresse du fabricant
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Société-mère du fabricant (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA