Events

Rappel de Device Recall Intact Disposable Wands

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 Advanced Energy, LLC.

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
    76130
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1129-2017
  • Date de mise en oeuvre de l'événement
    2016-12-28
  • Date de publication de l'événement
    2017-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152251
  • 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
    Instrument, biopsy - Product Code KNW
  • Cause
    Product sterility compromised due to breach of sterile barrier.
  • Action
    Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.

Device

Device Recall Intact Disposable Wands
  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
  • Description du dispositif
    Intact Disposable Wands (part of the Intact System) || 900-130: 5 Pack 30mm Disposable || Product Usage: || The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
  • Manufacturer
    Medtronic Advanced Energy, LLC

Manufacturer

Medtronic Advanced Energy, LLC
  • Adresse du fabricant
    Medtronic Advanced Energy, LLC, 180 International Dr, Portsmouth NH 03801-6837
  • 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