Events

Retiro De Equipo (Recall) de Device Recall HALO90 ULTRA Ablation Catheter Model 909200

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 Barrx Medical, Inc..

¿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
    58908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2745-2011
  • Fecha de inicio del evento
    2011-05-25
  • Fecha de publicación del evento
    2011-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100503
  • 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 & #38; coagulation & #38; accessories - Product Code GEI
  • Causa
    Complaints of malfunction of the halo ultra ablation catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.
  • Acción
    BARRX Medical, Inc. sent a "PRODUCT RECALL NOTIFICATION" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. B¿RRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The "Steps for Voluntary Recall" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to B¿RRX Medical Customer Service at 888-662-2779.

Device

Device Recall HALO90 ULTRA Ablation Catheter Model 909200
  • Modelo / Serial
    Model number: 90-9200: Serial numbers: F1013145; Exp 4/30/2013; F1013152, Exp 4/30/2013; F1013176, Exp 5/31/2013; F1013184, Exp 6/30/2013; F1013214, Exp 7/31/2013; F1013228, Exp 7/31/2013; F1013246, Exp 8/31/2013; F1013264, Exp 9/30/2013; F1013312, Exp 12/31/2013; F1013356, Exp 2/28/2014; F1013365. Ex0 2/28/2014; F1013370, Exp 3/31/2014; F1013377, Exp 3/31/2014.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China
  • Descripción del producto
    HALO Ultra Ablation Catheter: || Rx only; for use only with the Halo Flex Energy generator and accessories; || Manufactured in the USA at B¿RRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. || Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.
  • Manufacturer
    Barrx Medical, Inc.

Manufacturer

Barrx Medical, Inc.
  • Dirección del fabricante
    Barrx Medical, Inc., 540 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA