Retiro De Equipo (Recall) de Device Recall Penumbra brand Penumbra Coil System, Penumbra Coil 400

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 Penumbra 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Device, neurovascular embolization - Product Code HCG
  • Causa
    The diameter of a component of the device is out of tolerance specification; the delivery pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil.
  • Acción
    Penumbra sent an Urgent Voluntary Field Removal Notice dated March 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately inspect all stock of Penumbra Coil 400 and identify product from the Lots. Remove product from these Lots from inventory and place it in quarantine for return to Penumbra Inc. (Do not use product from these Lots). Complete and return the attached product identification/ return form with in 5 business days via fax to +1 510-217-6414. Penumbra employees will contact customer directly to arrange return and replacement of product. For questions call Regulatory Affairs at 510-748-3224 or e-mail


  • Modelo / Serial
    F17211, F17212, F17213, F17214, F17215, F17216, F17256, F17257, F17258, F17259, F17260, F17310, F17311, F17333, F17334, F17335, F17336, F17337, F17338, F17339, F17340, F17374, F17375, F17376, F17395, F17396, F17397, F17398, F17399, F17400, F17401, F17402, F17403, F17404, F17405, F17440, F17441, F17442, F17443, F17444, F17445, F17446, F17447, F17448, F17485, F17486, F17487, F17489, F17507, F17511, F17512, F17513, F17514, F17515, F17516, F17517, F17564, F17565, F17566, F17567, F17568, F17569, F17668, F17669, F17670, F17672, F17673, F17675, F17676, F17705, F17706, F17707, F17708, F17710, F17735, F17736, F17737, F17738, F17739, F17740, F17741, F17742, F17743, F17744, F17745, F17780, F17781, F17782, F17783, F17790, F17791, F17792, F17793, F17794, F17833, F17834, F17835, F17836, F17837, F17838, F17839, F17840, F17841, F17842, F17843, F17844, F17900, F17901, F17902, F17903, F17904, F17905, F17906, F17907, F17908, F17924, F17925, F17926, F17927, F17928 , F17929, F17930, F17931, F17932, F17933, F17934, F17935, F17936, F17966, F17967, F17968, F17969, F17970, F17971, F17972, F17973, F17974, F17975, F17976, F17977, F17999, F18000, F18001, F18002, F18021, F18022, F18023, F18024, F18041, F18042, F18043, F18044, F18045, F18046, F18047, F18066, F18068, F18073, F18074, F18075, F18076, F18090, F18091, F18092, F18093, F18094, F18121, F18122, F18123, F18124, F18125, F18126, F18127, F18128, F18129, F18146, F18147, F18148, F18149, F18150, F18151, F18152, F18153, F18179, F18180, F18181, F18182, F18183, F18184, F18185, F18186, F18194, F18195, F18196, F18197, F18231, F18232, F18233, F18234, F18235, F18236, F18239, F18240, F18241, F18242, F18243, F18244, F18245, F18246, F18247, F18248, F18249, F18291, F18292, F18293, F18294, F18295, F18307, F18308, F18309, F18336, F18337, F18338, F18373, F18374, F18375, F18387, F18388, F18389, F18400, F18401, F18415, F18416, F18417, F18449, F18450, F18451, F18457, F18458, F18459, F18460, F18461, F18479, F18480, F18481, F18482, F18483, F18484, F18485, F18486, F18487, F18488, F18513, F18514, F18515, F18516, F18517, F18518, F18519, F18520, F18521, F18550, F18551, F18552, F18553
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.
  • Descripción del producto
    Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA || The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Microcatheter.
  • Manufacturer


  • Dirección del fabricante
    Penumbra Inc., 1351 Harbor Bay Pkwy, Alameda CA 94502-6541
  • Empresa matriz del fabricante (2017)
  • Source