Events

Rappel de Device Recall Medtronic DxTerity(TM) Diagnostic 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
    79591
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1479-2018
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • 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=162735
  • 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, intravascular, diagnostic - Product Code DQO
  • Cause
    Medtronic has determined that the french size indicator on the outer box may incorrectly reflect a 6 french size, rather than the correct 5 french size. the catheters inside the carton are the correct dxt5jl40 item, the inner pouch has all the correct labeling, and all the other information and configuration details are correct.
  • Action
    Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

Device

Device Recall Medtronic DxTerity(TM) Diagnostic Catheter
  • Modèle / numéro de série
    UDI 20643169689309, Lot Number 60074805
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
  • Description du dispositif
    Medtronic DxTerity(TM) Diagnostic Catheter, JL 4.0, 6F, REF DXT5JL40
  • 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