Events

Retiro De Equipo (Recall) de Device Recall BridgeAssurant

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 Ave 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
    25794
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0789-03
  • Fecha de inicio del evento
    2003-02-27
  • Fecha de publicación del evento
    2003-05-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26485
  • 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
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Causa
    During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.
  • Acción
    A letter was sent to each US commercial accounts via UPS overnight mailing on Saturday, March 1st, 2003 for delivery on Monday, March 3rd 2003. The notification instructs firm''s customers to sequester product from the specific lot numbers so that firm''s rep could assist in removing the affected product.

Device

Device Recall BridgeAssurant
  • Modelo / Serial
    Specific lots of 7 and 8 mm in diameter:  2E16E06, 2F05E10, 2F11E12, 2E15E01, 2F20E13, 2H06E02, V432C25E12, V432D04E14, 2D16E09, 2D29E08, 2E06E09, 2E28E15, 2G11E01, 2G10E01, 2H01E07, 2H15E06, 2K17E02, 2E21E01, 2H29E08, 2K24E02, V432D1E12, 2D12E12, 2D17E13, 2E10E13, 2E22E20, 2E24E10, 2E30E01, 2G15E01, 2G26E01, 2G24E10, 2K03E01, 2K17E01, 2L11E09, 2D30E02, 2E13E14, 2E21E14, 2E28E16, 2H19E18, 2L13E01, 2E07E13, 2E18E01, 2K23E02, 2E21E12, 2H06E03, V432C23E01, V432C29E11, 2D08E14, V432D05E12, 2D25E10, 2E16E16, 2G18E02, 2G26E23, 2H09E08, 2H14E05, 2K11E14, 2L07E06, 2E24E01, 2G24E11, 2H28E22, 2L08E04, V432C28E12, V432D02E09, 2D15E24, 2D24E13, 2E01E10, 2D18E12, 2E1415, 2E21E15, 2F24E13, 2G11E11, 2G17E01, 2G22E13, 2G26E01, 2H16E09, 2K15E03, 2K21E06, 2K21E05, 2L13E02, 2D24E12, 2D26E09, 2E15E25, 2F04E12, 2F18E13, 2H15E05, 2H21E10, 2J03E11, 2K03E07
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was released for distribution to 446 consignees nationwide. The recall was appropriately extended to the user level; i.e., Clinics, hospitals and medical Centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Descripción del producto
    Medtronic AVE brand Bridge¿Assurant¿ Balloon Expandable Stent Delivery System || for Biliary Catheter;Model #s: || FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; || FB720VL, FB730VL, FB820VL, FB830VL; || FB720F, FB730F, FB740F, FB760F, FB820F, FB830F, FB840F, FB860F; || FB720L, FB730L, FB820L, FB830L
  • Manufacturer
    Medtronic Ave Inc

Manufacturer

Medtronic Ave Inc
  • Dirección del fabricante
    Medtronic Ave Inc, 3576 Unocal Place, Santa Rosa CA 95403
  • Source
    USFDA