Devices

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.
  • 1 Event

Fabricante

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