Events

Rappel de Device Recall Heartport

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 Heartport 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
    27410
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0309-04
  • Date de mise en oeuvre de l'événement
    2003-10-02
  • Date de publication de l'événement
    2004-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-10-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30224
  • 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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Cause
    Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
  • Action
    Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.

Device

Device Recall Heartport
  • Modèle / numéro de série
    Lot Numbers 010367, 020342, 020378, 020379, 020380, 030353, 060358.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Description du dispositif
    DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT System, Product codes ED241, 242, 243, 244.
  • Manufacturer
    Heartport Inc

Manufacturer

Heartport Inc
  • Adresse du fabricant
    Heartport Inc, Route 22 West, Somerville NJ 08876
  • Source
    USFDA