Events

Retiro De Equipo (Recall) de Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.

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 Maquet Cardiovascular, LLC.

¿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
    60987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0967-2012
  • Fecha de inicio del evento
    2011-11-16
  • Fecha de publicación del evento
    2012-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106991
  • 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
    Stabilizer,heart - Product Code MWS
  • Causa
    There may be a small perforation in the sterile pouch of select lots of the acrobat v, acrobat suv, and acrobat mechanical stabilizers and the xpose 3 and xpose 4 positioners.
  • Acción
    Maquet sent an Urgent Device Removal Immediate Action Required letter dated November 16, 2011 and a Field Action Response forms via Federal Express to to affected customers. The letter identifies the problem, product. risk factors and actions to be taken. Customers were instructed to examine their stocks immediately to determine if they have any of the recalled product. If so, discontinue dispensing (distributing) the lot and complete the Field Action Response form attached to complete and fax the attached Field Action Response form. In addition, it provides instructions for how to return the recalled product to MAQUET. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271. If you have any additional questions, contact your local MAQUET Cardiovascul'ar sales representative or Customer Service at 1-888-880-2874 (6AM -5PM PST).

Device

Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.
  • Modelo / Serial
    Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  ACROBAT V Off Pump Vacuum Stabilizer OM-9100S  25038623, 25039921, 25040646, 25041091, 25042446, 25042522  ACROBAT SUV Off Pump Vacuum Stabilizer OM-9000S  25035819, 25037049, 25037461, 25037587, 25037871, 25037986, 25038109, 25038366, 25038500, 2503853, 25038947, 25039317, 25039450, 25039769, 25040040, 25040124, 25040530, 25040864, 25040945, 25041319, 25041599, 25041689, 25041954, 25042126, 25042237  ACROBAT Off Pump Mechanical Stabilizer OM-6000S  25040360, 25042190
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide
  • Descripción del producto
    ACROBAT Stabilizers- || ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) || Product Usage: || The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Dirección del fabricante
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA