Events

Rappel de Device Recall Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters,

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 Stryker Sustainability Solutions.

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
    79087
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0917-2018
  • Date de mise en oeuvre de l'événement
    2018-01-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161322
  • 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, recording, electrode, reprocessed - Product Code NLH
  • Cause
    An eeprom chip error code may occur when the catheters are used with carto ep navigation systems.
  • Action
    Stryker sent an Urgent Medical Device Recall letter dated January 2, 2018, explains the reason for recall, risk to health, and instructs them to discontinue use of the affected products. The customer is to check their inventory for the affected serial numbers provided in the attachment and complete the recall effectiveness check form to indicate the amount of product in inventory. Return instructions are provided. For further questions, please call (888) 763-8803.

Device

Device Recall Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagno...
  • Modèle / numéro de série
    Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
  • Description du dispositif
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. || The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
  • Manufacturer
    Stryker Sustainability Solutions

Manufacturer

Stryker Sustainability Solutions
  • Adresse du fabricant
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA