Events

Retiro De Equipo (Recall) de Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device

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 Micro Therapeutics Inc, Dba Ev3 Neurovascular.

¿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
    79463
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1701-2018
  • Fecha de inicio del evento
    2018-02-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162387
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Causa
    There is a potential issue for all mindframe capture devices to partially detach or separate from the delivery wire.
  • Acción
    The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.

Device

Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device
  • Modelo / Serial
    All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    MindFrame Capture LP Revascularization Devices: Product Numbers: || (a) REF 300010 || (b) REF 300011 || (c) REF 300012 || (d) REF 300013 || (e) REF 300014 || (f) REF 300015 || (g) REF 300016 || (h) REF 300017 || (i) REF 300018 || Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
  • Manufacturer
    Micro Therapeutics Inc, Dba Ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, Dba Ev3 Neurovascular
  • Dirección del fabricante
    Micro Therapeutics Inc, Dba Ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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