Events

Rappel de EverCross 0.035" OTW PTA Dilatation 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 Ev3, 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
    68034
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1489-2014
  • Date de mise en oeuvre de l'événement
    2014-04-09
  • Date de publication de l'événement
    2014-04-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126834
  • 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
    Covidien is recalling 2 production lots of evercross 0.035 pta balloon catheter because of a product labeling error. there is a discrepancy in the pta balloon length and the delivery catheter length printed on the product labeling.
  • Action
    Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.

Device

EverCross 0.035" OTW PTA Dilatation Catheter
  • Modèle / numéro de série
    AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
  • Description du dispositif
    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Adresse du fabricant
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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