Events

Retiro De Equipo (Recall) de Device Recall Cardioblate Gemini Surgical Ablation Device

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Cardiac Surgery Technologies.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    45940
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0727-2008
  • Fecha de inicio del evento
    2007-11-21
  • Fecha de publicación del evento
    2008-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66543
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    Mechanism failure: medtronic has identified an issue with four lots of the cardioblate gemini-s surgical ablation devices in which the polycarbonate distal coil retainer can fail during the course of a procedure, potentially resulting in an inability to apply the necessary jaw closure force.
  • Acción
    Certified letters were sent on 11/21/07 to Consignees. The letter identifies the issue with the device and requests that customers return the device back to the firm. Customers will be requested to complete a Field Correction Action certificate acknowledging the receipt of the information. For additional information you can contact a Medtronic Sales Representative at 763-391-9167.

Device

Device Recall Cardioblate Gemini Surgical Ablation Device
  • Modelo / Serial
    Lot Numbers: J243, J547, J548 and J656
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
  • Descripción del producto
    Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Model 49261). The device is intended for intermittent operation. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604.
  • Manufacturer
    Medtronic Cardiac Surgery Technologies

Manufacturer

Medtronic Cardiac Surgery Technologies
  • Dirección del fabricante
    Medtronic Cardiac Surgery Technologies, 7601 Northland Dr N, Minneapolis MN 55428-1088
  • Source
    USFDA