Events

Rappel de The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature.

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
    76955
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1922-2017
  • Date de mise en oeuvre de l'événement
    2017-04-05
  • Date de publication de l'événement
    2017-04-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154677
  • 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, Peripheral, Atherectomy - Product Code MCW
  • Cause
    Boston scientific is initiating a voluntary removal of two lots of jetstream sc 1.85mm and one lot of jetstream xc 2.1mm atherectomy catheters due to these units being mislabeled. some 1.85mm jetstream sc catheters may have been labeled as 2.1mm catheters, and some 2.1mm jetstream xc catheters may have been labeled as 1.85mm catheters.
  • Action
    Consignees were sent a Boston Scientific "Urgent Medical Device Removal" letter dated April 5, 2017. The letter was addressed to Materials Manager / Field Action Contact. The letter described the issue and the prduct involved in the recall. Advised consignees to segregate and return the affected product to Boston Scintific. This recall is to be carried to the customer level. Requested consginees to complete and return the Account Reply Verification Tracking Form. Contact your local Sales Representative can answer any questions that you may have regarding this Removal.

Device

The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treat...
  • Modèle / numéro de série
    18775553, 18775552, 18822086
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI. OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS
  • Description du dispositif
    The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 2 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