Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

Detalles del retiro

Fabricante

Abiomed, Inc.

Distribuidor

Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Lote

1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012, IC12015, IC12447, IC12483, IC12814, IC13029, IC13030, IC13031, IC9010, IC9011, IC9949, IC9950, IC10146, IC10180, IC10371, IC10372, IC10396, IC10397, IC10665, IC10670, IC10671, IC10673, IC10721, IC10772, IC10828, IC10835, IC11072, IC11116, IC11119, IC11132, IC11138, IC11140, IC11146, IC11679, IC11706, IC11712, IC11713, IC11721, IC11878, IC11951, IC11958, IC11967, IC11969, IC11978, IC11986, IC11992, IC11997, IC12260, IC12261, IC12446, IC12454, IC12458, IC12459, IC12463, IC12465, IC12466, IC12544, IC12546, IC12555, IC12565, IC12566, IC12586, IC12593, IC12594, IC12595, IC12596, IC12666, IC12670, IC12744, IC12747, IC12749, IC12750, IC12761, IC12764, IC12771, IC12810, IC12822, IC12828, IC12845, IC12929, IC13034, IC13035, IC13041, IC13047, IC13053, IC13118, IC13122, IC13135, IC13199, IC13226, IC13245, IC13246, IC13360, IC13364, IC13627, IC13635, IC13640, IC13642, IC12768, IC13023, IC13322, IC9071, IC9073, IC10126, IC10139, IC10169, IC10174, IC10392, IC10556, IC10558, IC10628, IC10632, IC10674, IC10677, IC10678, IC10680, IC11215, IC11217, IC11219, IC11220, IC11281, IC11283, IC11289, IC11358, IC11879, IC11904, IC11911, IC11930, IC11945, IC11952, IC11959, IC11960, IC11961, IC11966, IC11970, IC11973, IC11974, IC11976, IC11989, IC11991, IC12195, IC12206, IC12210, IC12213, IC12216, IC12217, IC12257, IC12258, IC12262, IC12265, IC12267, IC12269, IC12270, IC12272, IC12273, IC12274, IC12276, IC12277, IC12307, IC12309, IC12310, IC12319, IC12455, IC12456, IC12457, IC12467, IC12481, IC12484, IC12485, IC12488, IC12491, IC12494, IC12548, IC12551, IC12553, IC12765, IC12767, IC12812, IC12816, IC12824, IC12835, IC12942, IC12951, IC13177, IC13192, IC13291, IC13298, IC13328, IC13329, IC13330, IC13331, IC13352, IC13354, IC13363, IC13365, IC13366, IC13628, IC13636, IC9726, IC9727, IC9729, IC9730, IC9761, IC9830, IC9959, IC9965, IC10154, IC10159, IC10171, IC10175, IC10394, IC10400, IC10938, IC10952, IC11305, IC11715, IC11722, IC12001, IC12220, IC12221, IC12524, IC12542, IC12671, IC12672, IC8840, IC9252, IC9757, IC9759, IC10779, IC10782, IC10181, IC10184, IC10185, IC10186, IC10326, IC10360, IC10369, IC10540, IC10541, IC10544, IC10551, IC10555, IC10559, IC10627, IC10639, IC10679, IC10682, IC10707, IC10710, IC10711, IC10713, IC10809, IC11007, IC11010, IC11011, IC11090, IC11221, IC11223, IC11234, IC11363, IC11368, IC11717, IC11718, IC11719, IC11910, IC11913, IC11931, IC11948, IC11949, IC11955, IC11980, IC11983, IC12259, IC12263, IC12264, IC12266, IC12281, IC12282, IC12290, IC12311, IC12314, IC12486, IC12490, IC12496, IC12497, IC12576, IC12577, IC12695, IC12696, IC12697, IC12698, IC12699, IC12700, IC12702, IC12703, IC12704, IC12753, IC12754, IC12755, IC12756, IC12757, IC12802, IC12809, IC13069, IC13072, IC13120, IC13121, IC13133, IC13134, IC13136, IC13138, IC13165, IC13213, IC13248, IC13249, IC13281, IC13282, IC13293, IC13297, IC13371, IC13372, IC13565, IC13638, IC13639, IC13643, IC13645, IC13650, IC13653, IC8821, IC8822, IC8823, IC8825, IC8826, IC9002A, IC9015, IC9023, IC9024, IC

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States