Events

Retiro De Equipo (Recall) de Device Recall Protege GPS 8mm x 40mm Self Expanding Peripheral Stent 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
    52642
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2025-2009
  • Fecha de inicio del evento
    2009-06-10
  • Fecha de publicación del evento
    2009-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84183
  • 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
    Diagnostic Biliary Catheter - Product Code FGE
  • Causa
    Ev3 inc. is conducting a voluntary recall of specific lots of the protege gps self-expanding stent system because labeling did not match the actual stent size contained in the package. the affected product was labeled as a 6mm x 80mm protege gps stent but actually contained an 8mm x 40mm stent. this situation can lead to vessel damage or inadequate coverage of the target lesion.
  • Acción
    Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".

Device

Device Recall Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System
  • Modelo / Serial
    Lot # 6691788
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    International Distribution Only -- Brazil, Uruguay, & Malaysia.
  • Descripción del producto
    ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120. || In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
  • 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