Events

Retiro De Equipo (Recall) de Device Recall Medtronic Everest 20cc Inflation 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 Medtronic Vascular.

¿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
    67490
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1121-2014
  • Fecha de inicio del evento
    2014-02-06
  • Fecha de publicación del evento
    2014-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125544
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Causa
    Incorrect master label.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter on February 6, 2014, via UPS 3-day delivery. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product that remains in their inventory. Return the affected product to Medtronic: Contact Customer Service at 888-283-7868 and reference RADAR # 170276 to initiate a return and credit of product. Complete the attached Customers Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If any affected product has been forwarded to another facility, customers were asked to notify that facility accordingly and facilitate the retrieval of the affected product. Customers with questions were instructed to contact their Medtronic representative. For questions regarding this recall call 888-283-7868.

Device

Device Recall Medtronic Everest 20cc Inflation Device
  • Modelo / Serial
    Lot Number: 50755851
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including TX, ME, IA, PA, OR, and NH.
  • Descripción del producto
    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P || The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Dirección del fabricante
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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