Events

Rappel de Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent 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 Cordis 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
    47347
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1556-2008
  • Date de mise en oeuvre de l'événement
    2008-03-10
  • Date de publication de l'événement
    2008-07-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69267
  • 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
    Iliac Stent - Product Code NIO
  • Cause
    Data transcription error. the 10 affected lots of catalog number c10040sl were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. this condition may result in a separation of the device. if a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel.
  • Action
    A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.

Device

Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System
  • Modèle / numéro de série
    10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Japan and Canada.
  • Description du dispositif
    CORDIS S.M.A.R.T.¿ Control" Nitinol Stent System || Model Number(s): C10040SL, Manufactured in Mexico. || Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Adresse du fabricant
    Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA