Events

Rappel de Device Recall RX Accunet Embolic Protection 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 Abbott 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
    60906
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0757-2013
  • Date de mise en oeuvre de l'événement
    2011-11-30
  • Date de publication de l'événement
    2013-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106763
  • 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
    Temporary Carotid Catheter for Embolic Capture - Product Code NTE
  • Cause
    The recall was initiated because abbot vascular has discovered that the identified lots of the rx accunet embolic protection system may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
  • Action
    Abbott Vascular sent an "URGENT DEVICE RECALL" letter dated November 30, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to work with their local account representative to review their inventory, complete the attached Field Action Reconciliation/ Effectiveness Check Form and return any unused identified products to Abbott Vascular.

Device

Device Recall RX Accunet Embolic Protection System
  • Modèle / numéro de série
    Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
  • Description du dispositif
    Brand Name: RX Accunet Embolic Protection System || Common Name: RX Accunet EPS. || Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. || The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Adresse du fabricant
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA