Events

Rappel de Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories

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 Atricure 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
    64404
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0912-2013
  • Date de mise en oeuvre de l'événement
    2013-01-14
  • Date de publication de l'événement
    2013-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116050
  • 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
    Surgical device, for ablation of cardiac tissue - Product Code OCL
  • Cause
    Products from lot no. 41865 may have been sent out with incorrect instructions for use (ifu) labeling.
  • Action
    AtriCure sent a Urgent Medical Device Recall/Correction letter dated January 14, 2013, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. AtriCure has identified that products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling. If the MAX1 is used as intended there is no risk to the patient as a result of this issue. The correct instructions for Use for the MAX1 Pen is included with this notification. AtriCure will replace any affected product if requested by the facility. Please review and fill out the attached " Acknowledgement Form" and either fax to AtriCure at (513) 644-4753. If you need to contact customer service, their number is 1-866-349-2342.

Device

Device Recall Isolator Linear Pen, Electrosurgical cutting and coagulation device and accessories
  • Modèle / numéro de série
    Model Number(s): MAX1 A000163, Lot Number 41865
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of MD, PA and TX.
  • Description du dispositif
    Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
  • Manufacturer
    Atricure Inc

Manufacturer

Atricure Inc
  • Adresse du fabricant
    Atricure Inc, 6217 Centre Park Drive, West Chester OH 45069
  • Société-mère du fabricant (2017)
    Atricure Inc
  • Source
    USFDA