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  • Dispositivo 554
  • Fabricante 123
  • Evento 124969
  • Implante 35
S.M.A.R.T. Flex Vascular Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de S.M.A.R.T. Flex Vascular Stent System
Cordis PRECISE PRO RX stentsystem of nitinol
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Cordis PRECISE PRO RX stentsystem of nitinol
OPTEASE temporary vena cava filter
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant
  • Manufacturer
    Cordis Cashel
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de OPTEASE temporary vena cava filter
affected lots of the coronay stent “Cypher Select ™+“
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de affected lots of the coronay stent “Cypher Select ™+“
S.M.A.R.T. CONTROL Nitinol Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant-endovascular-therapeutic
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de S.M.A.R.T. CONTROL Nitinol Stent System
S.M.A.R.T. Flex Vascular Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant
  • Manufacturer
    Cordis, a Cardinal Health Company
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de S.M.A.R.T. Flex Vascular Stent System
S.M.A.R.T. Nitinol Stent System and S.M.A.R.T. CONTROL Nitinol Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant-endovascular-therapeutic
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de S.M.A.R.T. Nitinol Stent System and S.M.A.R.T. CONTROL Nitinol Stent System
Cypher Select® + Sirolimus-eluting Coronary Stents
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Cypher Select® + Sirolimus-eluting Coronary Stents
all unexpired lots of „S.M.A.R.T. CONTROL“ Nitinol Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de all unexpired lots of „S.M.A.R.T. CONTROL“ Nitinol Stent System
the S.M.A.R.T. ® Nitinol Stent System and S.M.A.R.T. ® CONTROL ® Nitinol Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the S.M.A.R.T. ® Nitinol Stent System and S.M.A.R.T. ® CONTROL ® Nitinol Stent System
OptEase retrievable vena cava filters (articles no. 466F210A und 466F210B)
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de OptEase retrievable vena cava filters (articles no. 466F210A und 466F210B)
PRECISE PRO RX Nitinol Stent System
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de PRECISE PRO RX Nitinol Stent System
specific lots of the ExoSeal™Vascular Closure Device listed below
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis Corp.
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de specific lots of the ExoSeal™Vascular Closure Device listed below
Device Recall S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC
  • Modelo / Serial
    Catalog Numbers: C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
  • Descripción del producto
    S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC: Self-Expanding Vascular Stents delivered by catheter for the indication of improving luminal diameter in patients with symptomatic atherosclerotic disease of the iliac arteries. catalog numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T.¿ CONTROL¿ in the logo/description. All unexpired lots from 15112447 through 15525516.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall S.M.A.R.T. CONTROL NITINOL STENT SYSTEM ILIAC
Device Recall Cordis PRECIS (R) Rx Nitinol Stent System
  • Modelo / Serial
    Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
  • Descripción del producto
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cordis PRECIS (R) Rx Nitinol Stent System
Device Recall Cordis S.M.A.R.T. Flex Vascular Stent System
  • Modelo / Serial
    1.) Catalog Numbers SF05200MV, Size 5 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066829 Lot #'s: 34551, 34552, 34585, 34586, 34587, 35009, 35199, 35228, 35706, 35741, 35859, 35860, 36160, 36275, 36380, 36666, 36792, 36859, 36902, 36903, 37007, 37091, 37155, 37349, 37350, 37350, 37961, 37962, 38059, 38315, 38515, 38529, 38529, 38628, 38629, 39001, 39002, 39195, 39398, 39427, 39644, 39862, and 39974 2.) Catalog Numbers SF05200SV, Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032066409 Lots #'s: 35707, 35742, 35965, 36161, 36667, 36793, 37351, 37963, 39158, 39351, 39352, 39554, 39641, and 39863 3.) Catalog Numbers SF06200MV, Size 6 x 200mm, Catheter length 120 cm GTIN -Carton Level 20705032066836 Lots #'s: 34469, 34470, 34588, 34589, 34823, 3487534993, 35006, 35068, 35069, 35229, 35287, 35352, 35469, 35470, 35715, 35755, 35823, 35868, 35945, 35971, 36032, 36033, 36163, 36279, 36322, 36388, 36537, 36678, 36742, 36804, 36865, 37019, 37106, 37168, 37250, 37352, 37707, 37975, 38063, 38282, 38319, 38429, 38513, 38569, 38747, 38850, 38921, 39007, 39162, 39200, 39267, 39358, 39405, 39949, and 39955 and  4.) Catalog Numbers SF06200SV Size 5 x 200mm, Catheter length 80 cm GTIN -Carton Level 20705032067024 Lots #'s 35077, 35165, 35361, 35500, 35568, 35597, 35716, 35756, 35824, 35946, 35972, 36034, 36164, 36538, 36679, 36680, 36805, 37107, 37169, 37541, 37579, 37708, 38064, 38167, 38168, 38320, 38321, 38530, 38748, 39201, 39439, 39440, 39645, 39646, 39959, and 39971   ALL UNEXPIRED LOTS NUMBERS
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    FOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM
  • Descripción del producto
    Cordis S.M.A.R.T. Flex Vascular Stent System
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cordis S.M.A.R.T. Flex Vascular Stent System
Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and C...
  • Modelo / Serial
    Lot # 50704127, 50804011, 40804419, 40804422, 40804454, 40904372, 50704295, X0704425, X0804127, X0904342, 40904373, A0804001, A0804816, X0904265, 40904407, X0704674, X0704943, A0804485, X0804498, A0804786, A0804849, 50704343, 50704422, X0704677, A0804002, A0904352, 50704126, A0804006, 40804658, 40904376, 50804311, 50804326, 40804467, X0804725, A0804846, 40904398, 50704344, A0804150, 50804168, X0804215, 40804453, X0904164, 40904400, A0904471, 40804200, A0904347, 40904409, A0904703, X0804723, A0804944, 50704423, 40804034, 50804211, 40804471, 40804477, 50804309, 40804433, X0804442, X0704098, 50704144, 50704282, 50704424, X0904073, A0904738, X0804214, A0804948, A0904349, 40904404, 40904413, A0904807, X0704825, A0904808, X0704961, 50804312, X0804370, 40804479, X0804495, A0804847, 40804201, X0804260, 40904369, 40904412, A0704263, 50704442, A0704528, 50804416, X0804724, A0804946, 40904350, 40904351, 50704446, X0704575, X0704826, 40804434, 40804465, 40804615, 40904375, X0604561, X0704819, 40804033, 40804202, 40804421, A0804486, X0904122, 40904378, A0904607, A0904701, 50704443, A0704629, X0704944, 40804431, 40804473, X0804496, 40904322, A0904348, 40904367, A0904476, A0904477, A0904720, A0904775, 50704125, X0704428, 50704441, X0704577, A0704631, 40804032, X0804126, X0804390, 40804472, A0904034, 40904321, 40904333, 40904334, 40904353, A0904696, X0704241, 50804313, 50804457, 40804659, A0804945, 40904379, A0904635, A0904636, 50704570, X0704964, A0804198, A0804203, X0804369, X0804392, 40804418, X0804630, A0804970, X0904121, 40904338, A0904483, A0904484, A0904488, X0704820, X0704945, A0804008, 50804165, 40804203, 50804417, 40804429, A0804568, X0804629, X0904119, X0904120, 40904339, 40904340, 40904374, A0904491, A0904492, 40904853, 50804166, A0804201, 40804432, 40804481, A0804567, X0804631, X0804882, 40904382, A0904719, A0904739, A0904876, 50704445, X0704821, X0804721, 40804913, 40904342, 40904365, A0904495, A0904707, A0904858, A0904875, A0804005, X0804086, 50804213, X0804722, 40904366, A0904497, A0904498, A0904736, A0904774, 40904854, X0704962, A0804004, A0804303, 40804437, A0904346, 40904368, A0904500, A0904860, A0704096, 50704366, 50704444, A0804009, 40904320, A0904698, A0904809, A0904859, 50704027, X0704307, A0804007, A0804149, 50804310, 40804430, X0804441, X0804497, 40904345, 40904364, A0904501, A0904699, X0704673, X0704824, A0804388, X0804689, X0804878, X0904237, 40904385, 50704425, X0704822, 50804418, 40804420, X0804690, A0804757, A0804817, 40904347, 40904348, X0704963, A0804199, A0804246, 40904354, 40904377, 40904386, A0904547.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed nation wide.
  • Descripción del producto
    Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx
Device Recall Cypher sterile stent
  • Modelo / Serial
    Lot no. X1004212
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed throughout the United States.
  • Descripción del producto
    Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cypher sterile stent
the OPTEASE® Retrievable Vena Cava Filter
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
    Cordis
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the OPTEASE® Retrievable Vena Cava Filter
OPTEASE temporary vena cava filter
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • ¿Implante?
    Yes
  • Descripción del producto
    Implant
  • Manufacturer
    Cordis Cashel
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de OPTEASE temporary vena cava filter
FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)
  • Modelo / Serial
    28 Catalog Numbers   CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • Descripción del producto
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)
FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 80 cm Length)
  • Modelo / Serial
    32 Catalog Numbers   FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • Descripción del producto
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 80 cm Length)
FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 120 cm Length)
  • Modelo / Serial
    32 Catalog Numbers   FLX-50030-V2, FLX-60030-V2, FLX-70030-V2, FLX-80030-V2, FLX-50040-V2, FLX-60040-V2, FLX-70040-V2, FLX-80040-V2, FLX-50060-V2, FLX-60060-V2, FLX-70060-V2, FLX-80060-V2, FLX-50080-V2, FLX-60080-V2, FLX-70080-V2, FLX-80080-V2, FLX-50100-V2, FLX-60100-V2, FLX-70100-V2, FLX-80100-V2, FLX-50120-V2, FLX-60120-V2, FLX-70120-V2, FLX-80120-V2, FLX-50150-V2, FLX-60150-V2, FLX-70150-V2, FLX-80150-V2, FLX-50200-V2, FLX-60200-V2, FLX-70200-V2, FLX-80200-V2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • Descripción del producto
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de FLEXSTENT Femoropopliteal SelfExpanding Stent System (EU Commercial 120 cm Length)
Cordis OPTEASE Vena Cava Filter
  • Modelo / Serial
    15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533 15793939 15381573 15652041 15307999 15454044 15598216 15799364 15402503 15670744 15312441 15456163 15605008 15802178 15406808 15686286 15317387 15460104 15606053 15809353 15430934 15699350 15320551 15466748 15610330 15812239 15435039 15737306 15325507 15471008 15614689 15816462 15444313 15762046 15330287 15473247 15627966 15822489 15462543 15768649 15335203 15478342 15632159 15830469 15466749 15793940 15340786 15480569 15632931 15836564 15473249 15798681 15344590 15487383 15637332 15839559 15481997 15814435 15350806 15490348 15643482 15843764 15495653 15820539 15353473 15495652 15647053 15848940 15506862 15845139 15358769 15501261 15652040 15855704 15525423 15854729 15366482 15501864 15656567 15857848 15543607 15860770 15370260 15505204 15659250 15863068 15375958 15513357 15667702 15870135 15380088 15518418 15670742 15875172 15385970 15522427 15675940 15878645 15386960 15526913 15683409 15884283 15386963 15529312 15690240 15896484 15389049 15530028 15694650 15918862 15391340 15535323 15698900 15925083 15396804 15538438 15704985 15932575 15400773 15544128 15707198 15932586 15406817 15546019 15736818 15950327 15408669 15551821 15742478 15961621 15409489 15556617 15747949
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.
  • Descripción del producto
    Cordis OPTEASE Vena Cava Filter || Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Cordis OPTEASE Vena Cava Filter
Device Recall Cordis PRECIS (R) PRO Rx Nitinol Stent System
  • Modelo / Serial
    Catalog Number: PC0520RXC, Lot Numbers: 17298513, 17340803; Catalog Number: PC0530RXC, Lot Numbers: 17283329, 17286330, 17333401 and 17376719; Catalog Number: PC0540RXC, Lot Numbers: 17295225 , 17312647, 17337070 and 17366679; Catalog Number: PC0620RXC, Lot Numbers: 17256203, 17264566, 17282136 and 17382573; Catalog Number: PC0630RXC, Lot Numbers: 17255095, 17264568, 17287132, 17294353, 17306044, 17308314, 17328366, 17337071, 17364507, 17388949 and 17392573; Catalog Number: PC0640RXC, Lot Numbers: 17249849, 17264995, 17283330, 17296211, 17331381, 17356085, 17364567, 17370803 and 17392574; Catalog Number: PC0720RXC, Lot Numbers: 17249850 and 17260987; Catalog Number: PC0730RXC, Lot Numbers: 17256214, 17264569, 17276754, 17290641, 17322268,17332269, 17341779, 17347010, 17357107, 17361603, 17381650 and 17386230;   Catalog Number: PC0740RXC, Lot Numbers: 17250948, 17253599, 17264571, 17282140, 17287345, 17295226, 17308316, 17322270, 17325372, 17331383, 17335082, 17344455, 17351475, 17361605, 17371407 and 17378613; Catalog Number: PC0820RXC, Lot Numbers: 17260988 and 17347026; Catalog Number: PC0830RXC, Lot Numbers: 17250952, 17256217, 17259977, 17265886, 17270630, 17280875, 17291876, 17294239, 17323767, 17328144, 17335802, 17340809,17349810, 17357109, 17360669, 17364569, 17369477,17376721, 17379881, 17381652 and 17388950;   Catalog Number: PC0840RXC, Lot Numbers: 17247325, 17251834, 17259051, 17264572, 17276782, 17287346, 17296212, 17306048,17321489,  17325375, 17328145,17335084, 17335085, 17346758, 17346759, 17349811,   17356086, 17360672, 17364570, 17370806 and 17379882;  Catalog Number: PC0920RXC, Lot Numbers: 17269319 and 17388951; Catalog Number: PC0930RXC, Lot Numbers: 17251837, 17274483, 17290643, 17298514, 17312648, 17313248, 17349018 , 17357110, 17361606, 17366682 and 17393271;  Catalog Number: PC0940RXC, Lot Number: 17260989, 17264998, 17270632, 17272818, 17280877, 17307877, 17312649, 17319031, 17319032, 17329303, 17339531, 17349019, 17354593, 17386232, 17387886 and 17397607.  Catalog Number: PC1020RXC, Lot Number: 17314385;  Catalog Number: PC1030RXC, Lot Numbers: 17251838, 17268217, 17274485, 17283332, 17287135, 17313250, 17329304, 17344458 and 17397609;  Catalog Number: PC1040RXC, Lot Numbers: 17253601, 17259979, 17268219, 17282144, 17286334, 17290644, 17294357, 17298515, 17298516, 17310830, 17313251, 17316969, 17319035, 17319036, 17329305, 17329306,  17349020, 17354594, 17358957, 17364509, 17369479, 17375323, 17379887, 17388953, 17390538 and 17394539.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
  • Descripción del producto
    Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cordis PRECIS (R) PRO Rx Nitinol Stent System
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