Events

Rappel de Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.

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
    75813
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0938-2017
  • Date de mise en oeuvre de l'événement
    2016-11-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151371
  • 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
    Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Cause
    Boston scientific is conducting a recall on boston scientific ingevity" mri endocardial pacing leads. there is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
  • Action
    Boston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000.

Device

Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.
  • Modèle / numéro de série
    Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
  • Description du dispositif
    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • 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