Events

Rappel de Device Recall Taxus

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 Boston Scientific Scimed.

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
    29479
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1052-04
  • Date de mise en oeuvre de l'événement
    2004-07-01
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34107
  • 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
    Coronary Drug-Eluting Stent - Product Code NIQ
  • Cause
    On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
  • Action
    July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.

Device

Device Recall Taxus
  • Modèle / numéro de série
    No 2.25 mm lots were distributed in U.S. U.S Distributed - 2.5 mm - Lot number/Exp. Date: 6171851 May-04 U.S Distributed - 2.75 mm - Lot number/Exp. Date: 6294706 Jun-04 U.S Distributed - 3.0 mm - Lot number/Exp. Date: 6337153 Jul-04 6422009 Aug-04 6555155 Sep-04 6271481 Jun-04 U.S Distributed - 3.5mm - Lot number/Exp. Date: 6111269 Apr-04 No 4.0 mm lots distributed in U.S. No TAXUS OTW were sold outside the U.S.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • Adresse du fabricant
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA