Events

Rappel de Device Recall CONTAK RENEWAL AVT CRTD

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 Boston Scientific CRM Corp.

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
    32738
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1109-05
  • Date de mise en oeuvre de l'événement
    2005-07-25
  • Date de publication de l'événement
    2005-08-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-04-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40732
  • 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
    Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
  • Cause
    Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
  • Action
    Urgent Medical Device Safety Information & Corrective Action letter dated 07/22/05 was either mailed or Federal Expressed to doctors. This letter informed doctors that Guidant was revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. Contained in this letter were Clinical Implications and Revised Recommendations.

Device

Device Recall CONTAK RENEWAL AVT CRTD
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide. In addition to the US other countries include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
  • Description du dispositif
    CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Adresse du fabricant
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA