Events

Rappel de Device Recall CONTAK RENEWAL 4 AVT and CONTAK RENEWAL 4 AVT HE

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 Guidant 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
    32496
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0952-05
  • Date de mise en oeuvre de l'événement
    2005-06-24
  • Date de publication de l'événement
    2005-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40196
  • 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
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
  • Cause
    Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. when the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
  • Action
    Firm issued a Dr. Doctor letter dated 06/23/05. Letter informs physicians of the issue, clinical implications and recommendations. UPDATE: An Advisory Update, dated 08/01/05 is being issued to physicians to inform them of a new programmer software application upgrade and the programmer screen alerts. Additionally regulatory approval was given for a new switch component that will be incorporated into all Guidant CRT-D products.

Device

Device Recall CONTAK RENEWAL 4 AVT and CONTAK RENEWAL 4 AVT HE
  • Modèle / numéro de série
    all serial numers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • Description du dispositif
    CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 4 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Adresse du fabricant
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA