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;

Recall details

Manufacturer

Abiomed, Inc.

Distributor

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;

Lot

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

Risk classification

Class I

Area (FDA)

device

Country

United States