Events

Rappel de Device Recall Talent Thoracic Stent Graft System

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, 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
    61278
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1284-2012
  • Date de mise en oeuvre de l'événement
    2012-02-21
  • Date de publication de l'événement
    2012-03-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107703
  • 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
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Cause
    Complaints received related to the inability/difficulty to release the proximal (freeflow) bare stent using the tip capture mechanism.
  • Action
    Medtronic, Inc. sent an Urgent Medical Device Safety Information letter dated February 2012, to all affected customers. The letter identified the product, the problem, and the corrective action taken by Medtronic. Medtronic updated the Instructions for Use (IFU) manual. For questions regarding this recall call 707-566-1110.

Device

Device Recall Talent Thoracic Stent Graft System
  • Modèle / numéro de série
    TB2222C116CP, TF2424C116CP, TF2626C116CP, TF2828C116CP, TF3030C115CP, TF3232C115CP, TF3434C115CP, TF3636C114CP, TF3838C114CP, TF4040C114CP, TF4242C113CP, TF4444C113CP,  TF4646C112CP, TB2222C161CP, TF2424C161CP, TF2626C161CP, TF2828C161CP, TF3030C160CP, TF3232C160CP, TF3434C160CP, TF3636C159CP; TF3838C159CP, TF4040C159CP, TF4242C158CP, TF4444C158CP, TF4646C157CP, TB2222C201CP, TF2424C201CP, TF2626C201CP, TF2828C201CP, TF3030C200CP, TF3232C200CP, TF3434C200CP, TF3636C199CP, TF3838C199CP, TF4040C199CP, TF4242C198CP, TF4444C198CP, TF4646C197CP.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Talent Captivia Stent Graft System - FreeFlow configurations only. || Model numbers affected have the following designation: || TFXXXXXXXXCP and TBXXXXXXXXCP. || Medtronic Inc. || Santa Rosa, CA 95403. || The Talent¿ Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within a patients vasculature by excluding the lesion from blood flow and pressure.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Adresse du fabricant
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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