Events

Rappel de Medtronic Percutaneous Catheter Introducer Set

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 Medtronic, Inc..

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
    50078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0442-2009
  • Date de mise en oeuvre de l'événement
    2008-10-07
  • Date de publication de l'événement
    2008-12-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74672
  • 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 Introducer - Product Code DYB
  • Cause
    Failure to insert the guidewire through the 18 gauge introducer needle.
  • Action
    Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.

Device

Medtronic Percutaneous Catheter Introducer Set
  • Modèle / numéro de série
    Lot Number: 20105869 and 20111254
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • Description du dispositif
    6 F BardSelect 11cm Percutaneous Catheter Introducer Set || Ref: 060A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • Manufacturer
    Medtronic, Inc.

Manufacturer

Medtronic, Inc.
  • Adresse du fabricant
    Medtronic, Inc., 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Source
    USFDA