Events

Rappel de VNUS 7F ClosureFAST Catheter

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 VNUS Medical Technologies 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
    45510
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0542-2008
  • Date de mise en oeuvre de l'événement
    2007-08-08
  • Date de publication de l'événement
    2008-01-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65695
  • 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 - Product Code GEI
  • Cause
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • Action
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.

Device

VNUS 7F ClosureFAST Catheter
  • Modèle / numéro de série
    Lot #s:  319484,  274119,  274900,  275146,  275637,  276054,  277311,  277775,  278742,  279181,  279614,  279880,  279938,  280314,  280315,  280316,  285851,  286800,  287108,  287566,  288293,  292135,  292432,  293002,  293275,  293276,  293830,  293832,  294657,  294881,  294882,  295263,  296973,  298603,  299607,  299929,  300573,  301032,  301354,  302329,  302628,  303250,  303712,  303723,  304640,  304698,  305533,  305894,  306571,  306834,  307366,  307561,  307938,  307951,  308465,  309081,  309441,  309741,  309782,  310338,  310401,  310408,  310920,  311185,  312220,  312241,  312334,  313084,  313104,  313373,  313530,  313792,  314079,  314241,  314548,  314655,  315253,  315389,  315751,  315765,  315913,  315922,  316405,  316652,  316653,  316947,  317041,  317342,  317421,  318802,  319117, and  319253
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide
  • Description du dispositif
    VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
  • Manufacturer
    VNUS Medical Technologies Inc

Manufacturer

VNUS Medical Technologies Inc
  • Adresse du fabricant
    VNUS Medical Technologies Inc, 5799 Fontanoso Way, San Jose CA 95138-1015
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA