Events

Rappel de Medtronic

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
    30016
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1489-04
  • Date de mise en oeuvre de l'événement
    2004-09-15
  • Date de publication de l'événement
    2004-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35015
  • 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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Cause
    Spiral tip from dlp vad cannula may be loose and potentially detach during use.
  • Action
    A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.

Device

Medtronic
  • Modèle / numéro de série
    Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide throughout the United States and worldwide.
  • Description du dispositif
    Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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