Events

Rappel de Device Recall HEARTSTRING Aortic Cutter 4.3 mm

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 Maquet Cardiovascular.

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
    56860
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1222-2011
  • Date de mise en oeuvre de l'événement
    2010-06-04
  • Date de publication de l'événement
    2011-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94678
  • 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
    Surgical Cutter - Product Code FZT
  • Cause
    Pouch integrity may be compromised, resulting in loss of sterility.
  • Action
    Urgent Device Removal letters were sent out on June 10, 2020 by Federal Express. The letter identified the affected product, described the reason for the recall, and asked for all affected product to be returned. The firm asked customers to examine their inventory and to discontinue distributing the affected lots. In addition, customers are to complete and return the Field Action Response form. If the affected product was further distributed, those customers also need to be notified of the recall and return their affected product to their distributor. All affected returned products may be exchanged with other unaffected HEARTSTRING Aortic Cutter 4.3 MM devices. Customers are to contact their local MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874 to arrange for an exchange and if they have any questions.

Device

Device Recall HEARTSTRING Aortic Cutter 4.3 mm
  • Modèle / numéro de série
    Lot numbers 9081071 and 9082071.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of IA, KY, IL, WI, TX and NC and countries of Japan, Germany and Hong Kong.
  • Description du dispositif
    Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey. || Intended for use by cardiac surgeons during CABG procedures to create an opening in the wall of a vessel.
  • Manufacturer
    Maquet Cardiovascular

Manufacturer

Maquet Cardiovascular
  • Adresse du fabricant
    Maquet Cardiovascular, 170 Baytech Dr, San Jose CA 95134-2302
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA