Events

Rappel de Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery 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 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
    78570
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0188-2018
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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=159783
  • 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
    Stent, superficial femoral artery - Product Code NIP
  • Cause
    Stent length on the label may not match the length of the stent itself.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter on approximately 11/03/2017, via UPS 2-day delivery. Instructions include identify and quarantine all unused affected product in inventory, return all unused affected product, and complete and return the Customer Confirmation Certificate. Customers with questions regarding this communication, please contact your Medtronic Field Representative. For questions regarding this recall call 508-261-8000.

Device

Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery System
  • Modèle / numéro de série
    Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328.   Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
  • Description du dispositif
    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System || Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Adresse du fabricant
    Medtronic 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