Events

Retiro De Equipo (Recall) de Device Recall SilverHawk Peripheral Cutter Driver Plaque Excision System

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 Ev3, 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
    52299
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1162-2010
  • Fecha de inicio del evento
    2010-01-21
  • Fecha de publicación del evento
    2010-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82687
  • 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
    Atherectomy Peripheral Catheter - Product Code MCW
  • Causa
    Ev3 inc. is conducting a voluntary recall of specific lots of the silverhawk¿ cutter drivers (model number fg 02550) because of damage to the packaging.
  • Acción
    Consignees were sent an ev3 "Medical Device Recall" letter dated January 21, 2010. The letter was addressed to Cath Lab Manger/Risk Manager. The letter described the Issue Summary, Affected Product, and Required Action. The letter instructed customers to locate and remove from use the specified Cutter Driver(s). Customers are to complete and return the "Device Recall Field Action Reconciliation Form." An ev3 rep will assist in arranging for the return of all unused product and a replacement will be provided. Questions regarding the recall should be directed to ev3 Customer Service at 1-800-716-6700.

Device

Device Recall SilverHawk Peripheral Cutter Driver Plaque Excision System
  • Modelo / Serial
    7341279, 7426555, 7516513, 7584246, 7366716, 7470350, 7526519, 7696072, 7373759, 7481467, 7536344,  7381976, 7497872, 7555071,  7408387, 7505507, 7574961,    7341279, 7505507, 7555071,  7381976, 7516513, 7574961,  7408387, 7536344, 7696072,  7426555, 7481467,  7470350, and 7497872.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, with the exception of AK and VT, and countries of AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, FRANCE, GERMANY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, POLAND, SAUDI ARABIA, SOUTH KOREA, SPAIN, SWEDEN, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    SilverHawk¿ Peripheral Cutter Driver Plaque Excision System || REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., || Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Dirección del fabricante
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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