Events

Rappel de 9F Pruitt F3 Outlying Carotid Shunt with Tport

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 Lemaitre Vascular, 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
    60007
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0070-2012
  • Date de mise en oeuvre de l'événement
    2011-10-04
  • Date de publication de l'événement
    2011-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104225
  • 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
    Catheter, intravascular occluding, temporary - Product Code MJN
  • Cause
    Extended expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05.
  • Action
    The firm, LeMaitre Vascular, Inc., sent an "URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. If you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.

Device

9F Pruitt F3 Outlying Carotid Shunt with Tport
  • Modèle / numéro de série
    Lot Number: PFT2209
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.
  • Description du dispositif
    LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port || The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • Adresse du fabricant
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA