Events

Rappel de Device Recall 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation 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 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
    67437
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0969-2014
  • Date de mise en oeuvre de l'événement
    2014-02-04
  • Date de publication de l'événement
    2014-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125451
  • 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
    Catheter, angioplasty, peripheral, transluminal - Product Code LIT
  • Cause
    Boston scientific is initiating this recall removal of one lot of the coyote" over-the-wire pta balloon dilatation catheter and one lot of the coyote" monorail" pta balloon dilatation catheter. boston scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. to date, boston scientific has received three complaints for this issue. t.
  • Action
    Consignees were sent a Boston Scientific " Urgent Medical Device Recall Removal" letter on 2/4/2014. The letter was addressed to Materials Manager and Field Action Contact. The letter described the product involved in the recall and the problem. Advised consignees to segregate the affected lots and return to Boston Scientific in accordance to the enclosed recall instructions. The instructions also requested consignees to complete and return the Account Reply Verification Tracking Form (RVTF).

Device

Device Recall 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation Catheter
  • Modèle / numéro de série
    16397693
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.
  • Description du dispositif
    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
  • 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