Events

Rappel de Device Recall Maquet Datascope, Corp. Inc.

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 Datascope Corp - Cardiac Assist Division.

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
    69863
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1062-2015
  • Date de mise en oeuvre de l'événement
    2014-12-16
  • Date de publication de l'événement
    2015-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131722
  • 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
    Ferrule cap was not removed on some fiber-optic sensation and sensation plus iabc demonstration units. if fiber-optic connector is inserted into the maquet cs300 or cardiosave iabp, cap will prevent connection of unit and may become dislodged and remain in iabps fiber-optic receptacle.
  • Action
    Maquet Inc. sent a Product Recall Medical Device Field Correction letter/Field Correction response form, dated 12/16/2014 via Fed Ex. The letter identified the affected product and the reason for the recall. Users were asked to inspect their inventory for the affected units. If customers have any affected product, they are to follow the instructions provided. Additionally, users are to complete and return the attached Field Correction Response Form to acknowledge receipt of the letter and to indicate completion of the steps outlined. Completed forms should be returned by e-mailing a scanned copy to fieldactions@maquet.com or faxing a copy to 1-973-396-3607. Technical questions should be directed to the Technical Support Department at 1-800-777-4222.

Device

Device Recall Maquet Datascope, Corp. Inc.
  • Modèle / numéro de série
    Sensation 7 fr.34 cc IAB Demonstration Unit  0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469  Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470  Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units  0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568  Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576  Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx || An electromechanical system used to inflate and deflate intra-aortic balloons.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Adresse du fabricant
    Maquet Datascope Corp - Cardiac Assist Division, 1300 MacArthur Blvd., Mahwah NJ 07430-2052
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA