Events

Rappel de 6F Taiga Guiding 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 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
    79449
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1207-2018
  • 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=162346
  • 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
    Complaints regarding 6f taiga guide catheter tip detachment and/or tip splitting.
  • Action
    A recall notification was sent to all costumers in September 2017. Customers actions to be done: Identify and quarantine all unused affected products as listed in your inventory. Share notification with others who need to be aware where affected product may have potentially been transferred.

Device

6F Taiga Guiding Catheter
  • Modèle / numéro de série
    Lot/Serial Number's: 0008104881, 0008185945, 0008448845, 0008498609, 0008591678, 0008603130, 0008128237, 0008185937, 0008359341, 0008381347, 0008520748, 0008572204, 0008584614, 00 887489, 0008132544, 0008143685, 0008153935, 0008176874, 0008181991, 0008189749, 0008195422, 0008220305, 0008399842, 0008411526, 0008479077, 0008498645, 0008510155, 0008560305, 0008588040, 0008609897, 0008614083, 0008092512, 0008117850, 0008171020,  0008173080, 0008185946, 0008195426, 0008250618, 0008374572, 0008399835, 0008411525, 0008510141, 0008584625, 0008589932, 0008609899, 0008084699, 0008092511, 0008143683, 0008156792, 0008169119, 0008191347, 0008448842, 0008479041, 0008498608,  0008527623, 0008090683, 0008121917, 0008128241, 0008148608, 0008169116, 0008191339, 0008401589, 0008503947, 0008510133, 0008580930, 0008580935, 0008580939, 0008589915, 0008121924, 0008132534, 0008150901, 0008401588, 0008418561, 0008441398,  0008448854, 0008503956, 0008588042, 0008603140, 0008614065, 0008087481, 0008090682, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Japan
  • Description du dispositif
    6F Taiga Guiding Catheter
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, NE Mailstop LS245, 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