Events

Rappel de THERMOCOOL SMARTTOUCH

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 Biosense Webster, Inc..

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
    78129
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0054-2018
  • Date de mise en oeuvre de l'événement
    2017-09-06
  • 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=158735
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Cause
    Biosense webster, inc. has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for certain lots of thermocool brand catheters. alert 402 implies a "map: magnetic distortion" when connected to carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy.
  • Action
    All US and OUS customers, who have purchased the lots identified as part of this recall will be notified via customer letters in order to return the product to BWI facility where it will be segregated for further disposition. This product recall applies to hospitals (or direct customers) and distributors who have purchased and/or received the THERMOCOOL Catheters identified as part of this recall . One notification package which includes the Customer Notification Letter, Business Reply Form (B RF) and pre-paid return label will be distributed to the customers subject to this recall via a 3rd party vendor (Stericycle) for USA. OUS customer communication will occur in accordance with local regulations.

Device

THERMOCOOL SMARTTOUCH
  • Modèle / numéro de série
    17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China
  • Description du dispositif
    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA