Events

Rappel de Device Recall Maverick 2" Monorail PTCA 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 Boston Scientific 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
    48608
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2166-2008
  • Date de mise en oeuvre de l'événement
    2005-11-01
  • Date de publication de l'événement
    2008-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-09-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71721
  • 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
    Percutaneous Catheter - Product Code LOX
  • Cause
    Two lots may not be correctly labeled. specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
  • Action
    Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned.

Device

Device Recall Maverick 2" Monorail PTCA Catheter
  • Modèle / numéro de série
    Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
  • Description du dispositif
    Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-1225 || Use before 2007-01 || UPN H7493892812250 || Sterilized with ethylene oxide gas || Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-2035 || Use before 2007-01 || UPN H7493892820350 || Sterilized with ethylene oxide gas || Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA