Events

Rappel de Device Recall SteeroCathDx Diagnostic 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 Corp.

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
    47388
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1618-2008
  • Date de mise en oeuvre de l'événement
    2008-02-14
  • Date de publication de l'événement
    2008-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69388
  • 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
    Cardiac Catheter - Product Code DRF
  • Cause
    Package sterile barrier may be breached, compromising sterility.
  • Action
    Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com.

Device

Device Recall SteeroCathDx Diagnostic Catheter
  • Modèle / numéro de série
    Model Numbers M0042027BL0 (Lot#: 0011092878, 0011092882, 0011107097) and M0042028BL0 (Lot#: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879, 0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604, 0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
  • Description du dispositif
    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Adresse du fabricant
    Boston Scientific Corp, 150 Baytech Drive, San Jose CA 95134
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA