Events

Rappel de Liberte Monorail and OvertheWire Coronary Stent Systems

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
    53435
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0068-2010
  • Date de mise en oeuvre de l'événement
    2009-09-11
  • Date de publication de l'événement
    2009-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85496
  • 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
    Stent, coronary - Product Code MAF
  • Cause
    Boston scientific initiated a field correction for the liberte¿ bare-metal coronary stent products. they have received reports from cardiac cath labs that taxus liberte paclitaxel-eluting (taxus¿ libert¿¿ drug-eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a liberte¿ bare-metal stent, and libert¿¿ bare-metal stents have been ina.
  • Action
    Boston Scientific issued an "Urgent Medical Device Field Correction" letter dated September 18, 2009. The letter was addressed to Risk Manger/Field Action Contact. The letter described the product, problem and actions which included renaming the Liberte¿¿ Bare-Metal stent as VeriFlex" Bare-Metal stent. Enclosed with the letter included the Direction for Field Correction and a Reply Verification Tracking Form. For further information, contact you local Boston Scientific Sales Representative or call 1-800-811-3211.

Device

Liberte Monorail and OvertheWire Coronary Stent Systems
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico.
  • Description du dispositif
    Boston Scientific Liberte¿¿ Monorail¿ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". || The Liberte¿¿ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¿ Monorail¿ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¿ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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