Events

Retiro De Equipo (Recall) de Device Recall Mullins Transseptal Catheter Introducer Sheath

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 Inc. Cardiac Rhythm Disease Management.

¿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
    65757
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1876-2013
  • Fecha de inicio del evento
    2013-07-08
  • Fecha de publicación del evento
    2013-08-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120059
  • 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
    Medtronic identified a specific labeling issue for specific lots of mullins transseptal catheter introducer sheath, model 008551, in which packages labeled as mullins 7f (french) may actually contain an 8f(french) dilator. medtronic is requesting the return of potentially mis-labeled mullins transseptal catheter introducer 7 french sheaths. due to the differences in size, an 8f dilator will not.
  • Acción
    Consignees were sent on 7/8/2013 a Medtronic, Inc " Urgent Medical Device Recall" letter dated 8 July 2013. The letter was addressed to Healthcare Professionals. The letter identified the problem and the product involved in the recall. Advised consignees to remove and quarantine the product from their inventory and return the product. Requested consignees to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. If the product has been further distributed advised consignees to please notify them of the recall.

Device

Device Recall Mullins Transseptal Catheter Introducer Sheath
  • Modelo / Serial
    Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
  • Descripción del producto
    Medtronic Mullins Transseptal Adult 7F, REF 008551. || Intended for the introduction of cardiovascular catheters into the left side of the heart.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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