Events

Retiro De Equipo (Recall) de Device Recall Catheter Introducer

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 Biocardia, 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
    67712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1301-2014
  • Fecha de inicio del evento
    2014-03-03
  • Fecha de publicación del evento
    2014-03-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126128
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    Firm discovered the potential for particulates in the inner lumen of morph access pro steerable introducer, which could result in am embolic event.
  • Acción
    The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.

Device

Device Recall Catheter Introducer
  • Modelo / Serial
    Catalog number MAP645 -  Lot numbers:  1037  1048  1055  1059  1069  1073  1074  1079  1092  1095  1115  1118  1121  1125  1128  1130  1134  1147  1155  1164  1168  1169  1173  1177  1184  1190
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and country of: Israel.
  • Descripción del producto
    Morph AccessPro Steerable Introducer; || 6F Introducer, 45 cm working length || Single use only. || BioCardia, Inc. || San Carlos, CA 94070 || BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
  • Manufacturer
    Biocardia, Inc.

Manufacturer

Biocardia, Inc.
  • Dirección del fabricante
    Biocardia, Inc., 125 Shoreway Rd Ste B, San Carlos CA 94070-2718
  • Empresa matriz del fabricante (2017)
    BioCardia, Inc.
  • Source
    USFDA