Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter.

Detalles del retiro

Fabricante

Medtronic Neuromodulation

Distribuidor

Worldwide Distribution - USA (nationwide) including the states of AL,AR,AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of Austria, Belgium, Cyprus, Denmark, France, Germany, Iraq, Italy, Lebanon, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Uruguay.

Lote

Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following letter/number combinations are affected: N464184, N464200, N464206, N464254, N464257, N464258, N464262, N464263, N464264, N464271, N464693, N464703, N464708, N464725, N464727, N464730, N464734, N464736, N464738, N464742, N464746, N464750, N464752, N464841, N464924, N464930, N464995, N464995, N465020, N465038, N465063, N465065, N465073, N465082, N465088, N465091, N465094, N465111, N465125, N465129, N465131, N465136, N465138, N465144, N465145, N465146, N465148, N465150, N466065, N466067, N466067, N466068, N466069, N466071, N466072, N466075, N466134, N466167, N466177, N466196, N466201, N466240, N466244, N466259, N466289, N466290, N466291, N466306, N466368, N466390, N466392, N466394, N466398, N466399, N466631, N466639, N466645, N466678, N466678, N466754, N466758, N466761, N466886, N466897, N466901, N466902, N466911, N466914, N467103, N467109, N467113, N467114, N467116, N467126, N467138, N467171, N467180, N467183, N467192, N467193, N467194, N467195, N467197, N467198, N467203, N467204, N467206, N467209, N467351, N467351, N467352, N467355, N467356, N467357, N467395, N467399, N467401, N467402, N467407, N467444, N467451, N467453, N467454, N467563, N467568, N467570, N467601, N467606, N467608, N467609, N467611, N467612, N467614, N467618, N467621, N467626, N468288, N468343, N468401, N468404, N468406, N468406, N468448, N468494, N468500, N468507, N468510, N468511, N468514, N468516, N468519, N468522, N468574, N468580, N468621, N468622, N468624, N468626, N468641, N469182, N469262, N469332, N469360, N469360, N469388, N469420, N469422, N469428, N469431, N469433, N469434, N469436, N469438, N469440, N469446, N469447, N469449, N469452, N469460, N469465, N469466, N469469, N469474, N469478, N469507, N469511, N469530, N469533, N469549, N469579, N469583, N469586, N469588, N470163, N470197, N470234, N470303, N470307, N470401, N470408, N470414, N470420, N470424, N470453, N470459, N470919, N470923, N470929, N470931, N470931, N470934, N470938, N470940, N470941, N470951, N470953, N470954, N471442, N471443, N471446, N471447, N471448, N471449, N471487, N471488, N471490, N471490, N471491, N471764, N471791, N471840, N471853, N471856, N471860, N471863, N471864, N471865, N471866, N471870, N471871, N471875, N471880, N472310, N472326, N472333, N472336, N472342, N472345, N472347, N472857, N472861, N472866, N472868, N472873, N472875, N472876, N472878, N472882, N472885, N472886, N472890, N472894, N472900, N472905, N473140, N473144, N473148, N473154, N473156, N473176, N473178, N473180, N473202, N473207, N473211, N473221, N473222, N473223, N473228, N473230, N473311, N473311, N473323, N473377, N473401, N473426, N473438, N473492, N473493, N473989, N473996, N473999, N474001, N474005, N474006, N474007, N474010, N474018, N474019, N474023, N474027, N474037, N474038, N474047, N474047, N474421, N474423, N474427, N474431, N474433.

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States