Events

Retiro De Equipo (Recall) de Device Recall HT Connect Peripheral Guide Wire

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 Abbott Vascular, 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
    66971
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0558-2014
  • Fecha de inicio del evento
    2013-11-25
  • Fecha de publicación del evento
    2013-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124365
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    Abbott vascular has initiated a recall of the ht connect peripheral guide wires due to a small number of devices exhibiting partial delamination of the ptfe coating.
  • Acción
    Abbott Vascular sent an Urgent Device Recall letter dated November A recall communication letter dated November 25, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. The letter informs the customers of the 9 part numbers and 9 description of the products. Abbott Vascular is instructing the customers that the returned products will be replaced with similar products pending availability. Abbott Vascular has attached a customer response form for customers along with the customer notification letter. For questions regarding this recall call 951-914-2400.

Device

Device Recall HT Connect Peripheral Guide Wire
  • Modelo / Serial
    Part Number Lot Number 1012587 10097079 1012587 10168703 1012587 10168705 1012587 10171679 1012587 10262897 1012587 10281944 1012587 10303349 1012587 90021507 1012588 10087171 1012588 10087179 1012588 10108128 1012588 10108132 1012588 10137054 1012588 10137224 1012588 10155636 1012588 10155638 1012588 10156982 1012588 10171681 1012588 10181960 1012588 10186395 1012588 10187173 1012588 10201046 1012588 10201050 1012588 10202457 1012588 10213592 1012588 10213593 1012588 10220279 1012588 10220283 1012588 10220284 1012588 10226194 1012588 10226314 1012588 10226315 1012588 10226316 1012588 10226317 1012588 10226318 1012588 10244104 1012588 10303351 1012588 10303361 1012588 90020420 1012588 90020746 1012588 90021060 1012588 90021154 1012588 90021155 1012588 90021156 1012588 90021266 1012588 90021313 1012588 90021334 1012588 90021335 1012588 90021508 1012588 90021509 1012588 90021573 1012589 10087172 1012589 10087180 1012589 10087181 1012589 10087182 1012589 10087183 1012589 10108129 1012589 10108133 1012589 10111356 1012589 10111357 1012589 10118216 1012589 10122343 1012589 10137056 1012589 10156973 1012589 10157066 1012589 10167663 1012589 10171682 1012589 10171702 1012589 10181961 1012589 10187172 1012589 10187174 1012589 10187189  1012589 10194671 1012589 10200648 1012589 10202451 1012589 10202452 1012589 10219309 1012589 10219349 1012589 10220313 1012589 10220314 1012589 10220317 1012589 10222768 1012589 10226195 1012589 10226313 1012589 10237343 1012589 10239255 1012589 10239256 1012589 10239258 1012589 10239259 1012589 10265833 1012589 10281945 1012589 10281948 1012589 10288067 1012589 10294349 1012589 10294350 1012589 10298877 1012589 10300028 1012589 10303355 1012589 10303363 1012589 10303365 1012589 10305105 1012589 10305106 1012589 10309225 1012589 10309238 1012589 90020421 1012589 90020747 1012589 90020926 1012589 90021276 1012589 90021277 1012589 90021278 1012589 90021279 1012589 90021388 1012589 90021389 1012589 90021484 1012589 90021485 1012589 90021486 1012589 90021574 1012589 90021575 1012589 90021694 1012589 90021695 1012590 10127791 1012590 10281946 1012590 10309226 1012590 90021510 1012591 10087174 1012591 10087184 1012591 10105191 1012591 10118217 1012591 10137059 1012591 10168750 1012591 10171684 1012591 10181635 1012591 10194672 1012591 10202432 1012591 10219351 1012591 10220285 1012591 10220315 1012591 10234284 1012591 10234285 1012591 10234286 1012591 90020422 1012591 90020748 1012591 90020922 1012591 90021078 1012591 90021153 1012591 90021282 1012591 90021379 1012591 90021380 1012591 90021511 1012591 90021512 1012591 90021671 1012592 10087175 1012592 10087185 1012592 10087186 1012592 10108328 1012592 10111355 1012592 10122344 1012592 10137055 1012592 10155637 1012592 10156975 1012592 10156983 1012592 10171685 1012592 10181636 1012592 10194673 1012592 10194674 1012592 10202433 1012592 10202440 1012592 10202441 1012592 10219348 1012592 10219350 1012592 10225695 1012592 10227833 1012592 10227834 1012592 10227835 1012592 10240541 1012592 10244106 1012592 10252330 1012592 10265831 1012592 10303357 1012592 10309227 1012592 10309242 1012592 90020423 1012592 90020749 1012592 90020923 1012592 90021079 1012592 90021280 1012592 90021281 1012592 90021381 1012592 90021382 1012592 90021390 1012592 90021391 1012592 90021513 1012592 90021576 1012592 90021696 1012592 90021697 1012593 10148521 1012593 10281947 1012593 90021503 1012594 10087177 1012594 10105164 1012594 10118218 1012594 10122329 1012594 10148522 1012594 10168726 1012594 10181538 1012594 10194667 1012594 10198920 1012594 10198927 1012594 10213590 1012594 10213591 1012594 10220311 1012594 10220312 1012594 10220316 1012594 10222769 1012594 10226196 1012594 90020543 1012594 90020584 1012594 90020744 1012594 90021058 1012594 90021076 1012594 90021122 1012594 90021264 1012594 90021265 1012594 90021376 1012594 90021504 1012594 90021505 1012595 10087178 1012595 10101124 1012595 10118330 1012595 10122330 1012595 10148523 1012595 10171694 1012595 10181962 1012595 10193576 1012595 10194668 1012595 10194670 1012595 10198921 1012595 10198922 1012595 10198929 1012595 10220286 1012595 10220319 1012595 10220933 1012595 10220934 1012595 10220940 1012595 10232265 1012595 10232266 1012595 10232267 1012595 10252332 1012595 10265828 1012595 10309229 1012595 10309243 1012595 10311457 1012595 90020544 1012595 90020745 1012595 90021059 1012595 90021077 1012595 90021274 1012595 90021275 1012595 90021377 1012595 90021378 1012595 90021401 1012595 90021402 1012595 90021506 1012595 90021571
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa.
  • Descripción del producto
    HT Connect Peripheral Guide Wire || Part Number Description || 1012587 018 HT CONNECT 145 CM || 1012588 018 HT CONNECT 195 CM || 1012589 018 HT CONNECT 300 CM || 1012590 018 HT CONNECT FLEX 145 CM || 1012591 018 HT CONNECT FLEX 195 CM || 1012592 018 HT CONNECT FLEX 300 CM || 1012593 018 HT CONNECT 250T 145 CM || 1012594 018 HT CONNECT 250T 195 CM || 1012595 018 HT CONNECT 250T 300 CM
  • Manufacturer
    Abbott Vascular, Inc.

Manufacturer

Abbott Vascular, Inc.
  • Dirección del fabricante
    Abbott Vascular, Inc., 26531 Ynez Rd, Temecula CA 92591-4630
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA