Events

Rappel de Device Recall IntraAortic Balloon Catheter Mega 7.5FR 40cc

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 Datascope Corporation.

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
    79646
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1383-2018
  • Date de mise en oeuvre de l'événement
    2018-02-21
  • Date de publication de l'événement
    2018-04-16
  • 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=162890
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Cause
    The u.S. instructions for use for the mega intra-aortic balloon (iab) catheter was missing the contraindications section.
  • Action
    Maquet/Getinge issued a recall letter on February 21, 2018 to affected customers, via FEDEX with confirmation of delivery, to notify them of the fact that the IFU is missing the Contraindications section and to provide the missing information. Affected customers are instructed to examine their inventory immediately to determine if they have affected product. An Addendum to the Mega IAB Catheter IFU, containing the Contraindications, is provided as an attachment in the recall letter. It is suggested that affected customers post copies of the Addendum near all affected lot numbers of Mega IAB Catheters. Customers are provided with Maquet/Getinge contact information should their facility require a full copy of the correct Mega IAB Catheter IFU. Lastly, affected customers are instructed to complete and sign a response form, acknowledging that they have received the notification, and return the form to Maquet/Getinge.

Device

Device Recall IntraAortic Balloon Catheter Mega 7.5FR 40cc
  • Modèle / numéro de série
    0684 00 0295 01U and 0684 00 0295 02U
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc || Product Usage: || The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Adresse du fabricant
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-3206
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA