Events

Rappel de Device Recall Boston Scientific NexStent Monorail

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
    48697
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2141-2008
  • Date de mise en oeuvre de l'événement
    2008-06-06
  • Date de publication de l'événement
    2008-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71925
  • 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
    carotid stent and delivery system - Product Code NIM
  • Cause
    Tip detachment: boston scientific has received complaints involving a detachment of the tip from the nexstent carotid stent delivery system. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. since the potential for the tip to detach occurs during delivery of the sten.
  • Action
    Boston Scientific sent an urgent Voluntary Medical Device Recall letter, dated 06/06/08, to affected customers. The letter described the issue, identified affected product, requested to cease using or distributing the product and provided direction on how to return the recalled devices to Boston Scientific, Quincy, MA. A Reply Verification Tracking Form was asked to be returned to Boston Scientific. Since the issue is with the delivery system, patients already implanted with the stent are not affected.

Device

Device Recall Boston Scientific NexStent Monorail
  • Modèle / numéro de série
    US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203.   OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.
  • Description du dispositif
    Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
  • 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