Events

Rappel de Device Recall Accolade MRI and Essentio MRI pacemakers

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
    74812
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2749-2016
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • Date de publication de l'événement
    2016-09-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148506
  • 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
    Five accolate mri and essentio mri dr pulse generators with an alternate mics module configuration were shipped to us customers and implanted. this alternate configuration did not receive fda approval yet.
  • Action
    As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged.

Device

Device Recall Accolade MRI and Essentio MRI pacemakers
  • Modèle / numéro de série
    serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed to the states of TX, NH, MA, PA, and MN.
  • Description du dispositif
    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. || These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
  • 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