Events

Rappel de Device Recall Medtronic Zuma Guide 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 Medtronic Vascular.

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
    59111
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2754-2011
  • Date de mise en oeuvre de l'événement
    2011-06-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101234
  • 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, percutaneous - Product Code DQY
  • Cause
    Mislabeled; product labeled as 6f zuma guide with al 1.5 curve with side holes may contain a 5f zuma catheter with sal 1.0 curve.
  • Action
    The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.

Device

Device Recall Medtronic Zuma Guide Catheter
  • Modèle / numéro de série
    Lot # : 0005199588
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, and MA.
  • Description du dispositif
    Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes || Catalog Number: Z26AL15SH || The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Adresse du fabricant
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA