Events

Retiro De Equipo (Recall) de Device Recall XSizer Thrombectomy Catheter 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
    34708
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1107-06
  • Fecha de inicio del evento
    2006-02-14
  • Fecha de publicación del evento
    2006-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44517
  • 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
    Thrombectomy Catheter System - Product Code MCW
  • Causa
    Loss of operating vacuum during use-it has been determined that a small percentage of x-sizer thrombectomy catheter systems from specific lots may lose operating vacuum prematurely due to a system leak within the control module. this failure can lead to the inaility to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
  • Acción
    A medical Device Recall Letter dated 02/13/06 was sent to hospitals along the affected device lot numbers the hospital should have received on a Device Reconciliation Form. ev3 is asking for affected devices to be returned. Returned devices will be replaced at no cost.

Device

Device Recall XSizer Thrombectomy Catheter System
  • Modelo / Serial
    Model number XD-CS1150-45 (for US distribution), lot numbers: 782344, 782345, 782366, 782379, 782386, 782389,  782403, 782404, 782406, 782407, 782412, 782421, 782428,  782429, 782430, 782436, 782438, 782439, 782441, 782445,  782526, 986604, 986604, 986604, 986605, 986609, 986620,  986626, 986640, 986641, 986642, 986645, 986656, 986659,  1174394, 1174395, 1212529, 1229730, 1231296, 1234273,  1240986, 1241067, 1271238, 1272506, 1280664, 1280952,  1281088, 1282693, 1289590, 1289978, 1293902, 1295372,  1300605, 1302005, 1303572, 1308536, 1310238, 1362165.   Model number XR-CS1150-45 (for OUS distribution), lot numbers: 782773, 782777, 782787, 782788, 782790, 782791,  782795, 782796, 782797, 782798, 782800, 782801, 782804,  782808, 782811, 782812, 782816, 782818, 782822, 782848,  987054, 987055, 987056, 987058, 987059, 987062, 987063,  987064, 987065, 987066, 987067, 987070, 987070, 987070,  987071, 987073, 987076, 987078, 1057871, 1077841, 1077842, 1077843, 1077844, 1077846, 1077847, 1077848,  1077854, 1077856, 1077859, 1077862, 1095087, 1095089,  1296437, 1296552, 1313297, 1313502, 1313543, 1313562,  1313611, 1313645, 1314989, 1314991, 1314994, 1315002, 1315042, 1315058, 1315113, 1315140, 1315183, 1315211,  1315245, 1315292, 1315294, 1315313, 1315328, 1315365,  1315378, 1315383, 1315623, 1315624, 1315625, 1315626,  1315632, 1315633, 1315636, 1315639, 1315640, 1315644,  1315646, 1317128, 1317133, 1317134, 1317135, 1317144,  1317301, 1326969, 1326969, 1326969, 1326970, 1326972,  1326973, 1326974, 1326977, 1326982, 1326983, 1326998,  1326999, 1327006, 1327008, 1327011, 1327546, 1342794,  1342852, 1342874, 1342882, 1342888, 1342957, 1342980,  1343007, 1343019, 1343036, 1343045, 1343094, 1343108,  1343125, 1343136, 1343266, 1343273, 1343292, 1343314,  1363701, 1363712, 1363725, 1363742, 1363791, 1363827,  1363850, 1363974, 1363976, 1364006, 1364034, 1364049.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    World wide-AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. OUS to: Argentina, Australia, Austria, Brazil, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Jordan, Mexico, Netherlands, Norway, Pakistan, Portugal, Saudi Arabi, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom
  • Descripción del producto
    X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA.
  • Manufacturer
    Ev3, Inc

Manufacturer

Ev3, Inc
  • Dirección del fabricante
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA