Recall archive / FDA device enforcement

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions... — FDA record Z-3150-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 12, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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;
Reason: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 4100 units (2785 US, 1315 OUS) 11 10
Agency-reported status: Ongoing
Source record identifier: Z-3150-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, IC9051, IC9052, IC9072, IC9076, IC9077, IC9078, IC9106, IC9107, IC9108, IC9109, IC9110, IC9111, IC9112, IC9113, IC9114, IC9115, IC9169, IC9171, IC9176, IC9216, IC9217, IC9251, IC9253, IC9257, IC9260, IC9342, IC9345, IC9352, IC9424, IC9427, IC9762, IC9763, IC9764, IC9765, IC9766, IC9824, IC9945, IC9948, IC13709, IC13710, IC13711, IC13712, IC10123, IC10124, IC10127, IC10138, IC10140, IC10141, IC10142, IC10143, IC10144, IC10148, IC10152, IC10155, IC10157, IC10158, IC10161, IC10166, IC10173, IC10176, IC10256, IC10257, IC10258, IC10259, IC10260, IC10261, IC10262, IC10263, IC10264, IC10265, IC10329, IC10347, IC10370, IC10389, IC10393, IC10395, IC10398, IC10401, IC10404, IC10408, IC10415, IC10416, IC10423, IC10424, IC10425, IC10433, IC10434, IC10437, IC10438, IC10439, IC10440, IC10442, IC10468, IC10506, IC10510, IC10542, IC10543, IC10552, IC10591, IC10621, IC10633, IC10634, IC10635, IC10636, IC10638, IC10720, IC10738, IC10767, IC10768, IC10778, IC10781, IC10819, IC10858, IC10870, IC10883, IC10884, IC10898, IC10909, IC10917, IC10919, IC10939, IC10943, IC10944, IC10945, IC10947, IC10948, IC10949, IC10953, IC10954, IC10955, IC11003, IC11004, IC11005, IC11009, IC11095, IC11120, IC11122, IC11124, IC11127, IC11133, IC11136, IC11137, IC11141, IC11142, IC11149, IC11193, IC11209, IC11214, IC11224, IC11225, IC11226, IC11228, IC11233, IC11235, IC11277, IC11278, IC11279, IC11280, IC11286, IC11287, IC11288, IC11322, IC11328, IC11332, IC11334, IC11360, IC11361, IC11364, IC11367, IC11699, IC11705, IC11707, IC11708, IC11709, IC11710, IC11711, IC11900, IC11909, IC11928, IC11929, IC11934, IC11937, IC11942, IC11943, IC11946, IC11947, IC11950, IC11953, IC11954, IC11956, IC11957, IC11962, IC11963, IC11971, IC11975, IC11977, IC11981, IC11984, IC11985, IC11987, IC11988, IC11993, IC11995, IC12002, IC12014, IC12208, IC12212, IC12219, IC12222, IC12223, IC12271, IC12275, IC12280, IC12287, IC12289, IC12291, IC12308, IC12312, IC12313, IC12320, IC12442, IC12451, IC12453, IC12464, IC12470, IC12487, IC12493, IC12495, IC12523, IC12536, IC12538, IC12541, IC12550, IC12554, IC12556, IC12558, IC12567, IC12568, IC12574, IC12575, IC12585, IC12590, IC12591, IC12597, IC12640, IC12648, IC12667, IC12668, IC12673, IC12751, IC12759, IC12760, IC12763, IC12805, IC12807, IC12811, IC12821, IC12827, IC12829, IC12833, IC12834, IC12854, IC12865, IC12939, IC12940, IC12941, IC12944, IC12946, IC12947, IC12948, IC13003, IC13026, IC13036, IC13081, IC13097, IC13098, IC13100, IC13101, IC13103, IC13104, IC13105, IC13106, IC13107, IC13119, IC13137, IC13178, IC13183, IC13186, IC13292, IC13295, IC13296, IC13318, IC13319, IC13321, IC13332, IC13353, IC13355, IC13359, IC13367, IC13369, IC13370, IC13374, IC13731, IC13741, IC13751, IC13752, IC13762, IC13775, IC13777, IC13778, IC13779, IC13780, IC13806, IC8818, IC8819, IC8820, IC8824, IC8827, IC8836, IC8837, IC8838, IC8839, IC8841, IC8842, IC8865, IC8866, IC8868, IC8869, IC8870, IC8871, IC8872, IC8873, IC8874, IC8876, IC8898, IC8899, IC8900, IC8901, IC8902, IC8910, IC8911, IC8912, IC8913, IC8914, IC9000A, IC9001A, IC9003A, IC9004A, IC9009, IC9012, IC9013, IC9014, IC9016, IC9017, IC9019, IC9020, IC9021, IC9022, IC9039, IC9050, IC9069, IC9070, IC9075, IC9167, IC9168, IC9170, IC9172, IC9173, IC9174, IC9175, IC9179, IC9180, IC9189, IC9190, IC9191, IC9193, IC9194, IC9215, IC9254, IC9255, IC9256, IC9258, IC9259, IC9281, IC9330, IC9343, IC9389, IC9396, IC9398, IC9401, IC9425, IC9426, IC9429, IC9552, IC9553, IC9554, IC9555, IC9556, IC9643, IC9687, IC9689, IC9692, IC9693, IC9758, IC9760, IC9828, IC9868, IC9942, IC9944, IC9951, IC9954, IC9955, IC9956, IC9957, IC9958, IC9960, IC9966, IC9967, IC9968, IC12826, IC12831, IC13629, IC13647, IC9192, IC10560, IC10590, IC10698, IC10706, IC10773, IC10775, IC10799, IC10820, IC10885, IC10886, IC10890, IC10891, IC10892, IC10916, IC10920, IC10921, IC10940, IC10942, IC10946, IC10951, IC11074, IC11121, IC11229, IC11240, IC11302, IC11366, IC11714, IC11716, IC11914, IC11915, IC11964, IC11965, IC11968, IC11998, IC12000, IC12215, IC12218, IC12284, IC12288, IC12443, IC12444, IC12445, IC12452, IC12545, IC12552, IC12587, IC12762, IC12803, IC12815, IC12931, IC13017, IC13024, IC13091, IC13092, IC13099, IC13108, IC13109, IC13187, IC13294, IC9420, IC9428, IC9430, IC9431, IC9690, IC9827, IC9962, IC9964, IC10125, IC10156, IC10167, IC10168, IC10172, IC10183, IC10950, IC11999, IC12278, IC12480, IC12543, IC12766, IC12830, IC12933, IC13191, IC13247, IC13320, IC13356, IC13113, IC13127, IC13180, IC13193, IC10402, IC10403, IC10441, IC10505, IC10507, IC10508, IC10675, IC10676, IC12801, IC12808, IC9399, IC9402, IC9623, IC9626, IC9644, IC9645, IC9647, IC10153, IC10160, IC10580, IC10629, IC10887, IC10889, IC11006, IC11321, IC11323, IC11324, IC11326, IC11330, IC11331, IC11726, IC12013, IC12224, IC12549, IC12649, IC12786, IC12988, IC13020, IC13102, IC13132, IC13181, IC13184, IC9403, IC9404, IC9624, IC9646, IC9896, IC9946, IC9728, IC13142, IC13143, IC13144, IC13146, IC13148, IC13150, IC13151, IC13156, IC13157, IC13158; 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP; UDI-DI: 00813502011814; Serial Numbers: IC10016, IC10018, IC10019, IC10020, IC10021, IC10022, IC10068, IC10107, IC10119, IC10120, IC10272, IC10273, IC10274, IC10275, IC10276, IC10280, IC10290, IC10354, IC10355, IC10356, IC10357, IC10359, IC10363, IC10368, IC10405, IC10409, IC10413, IC10426, IC10427, IC10503, IC10504, IC10536, IC10537, IC10538, IC10539, IC10563, IC10583, IC10699, IC10700, IC10705, IC10806, IC10807, IC10810, IC10869, IC10906, IC10907, IC10928, IC10930, IC10931, IC10932, IC11088, IC11192, IC11195, IC11218, IC11253, IC11339, IC11340, IC11370, IC11376, IC11378, IC11405, IC11417, IC11453, IC11454, IC11459, IC11499, IC11570, IC11623, IC11636, IC11666, IC11672, IC11678, IC11687, IC11689, IC11690, IC11694, IC11720, IC11725, IC11727, IC11738, IC11743, IC11750, IC11751, IC11777, IC11778, IC12026, IC12028, IC12029, IC12030, IC12031, IC12404, IC12405, IC12434, IC12437, IC12438, IC12515, IC12516, IC12517, IC12518, IC12609, IC12610, IC12612, IC12613, IC12614, IC12617, IC12618, IC12619, IC12620, IC12752, IC12769, IC12775, IC12776, IC12841, IC12843, IC12846, IC12849, IC12852, IC12853, IC13258, IC13259, IC13324, IC13326, IC13392, IC13393, IC8196, IC8197, IC8237, IC8238, IC8239, IC8240, IC8241, IC8245, IC8246, IC8298, IC8299, IC8301, IC8302, IC8303, IC8304, IC8306, IC8309, IC8310, IC8364, IC8369, IC8370, IC8371, IC8372, IC8374, IC8375, IC8491, IC8492, IC8523, IC8524, IC8526, IC8531, IC8571, IC8573, IC8583, IC8595, IC8597, IC8599, IC8601, IC8619, IC8626, IC8666, IC8670, IC8679, IC8680, IC8681, IC8682, IC8684, IC8685, IC8687, IC8731, IC8732, IC8733, IC8734, IC8735, IC8779, IC8780, IC8782, IC8784, IC8785, IC8886, IC8887, IC8888, IC8889, IC8890, IC8892, IC8893, IC8894, IC8896, IC8897, IC8915, IC8916, IC8917, IC8918, IC8919, IC8921, IC8922, IC8923, IC8924, IC8927, IC8937, IC9125, IC9126, IC9127, IC9128, IC9129, IC9130, IC9131, IC9132, IC9134, IC9135, IC9136, IC9137, IC9138, IC9139, IC9140, IC9288, IC9289, IC9290, IC9291, IC9292, IC9294, IC9295, IC9298, IC9321, IC9322, IC9323, IC9325, IC9326, IC9329, IC9331, IC9332, IC9411, IC9462, IC9463, IC9485, IC9489, IC9490, IC9491, IC9492, IC9494, IC9495, IC9496, IC9497, IC9498, IC9499, IC9540, IC9559, IC9560, IC9561, IC9562, IC9563, IC9580, IC9694, IC9702, IC9703, IC9704, IC9705, IC9707, IC9708, IC9709, IC9786, IC9787, IC9790, IC9791, IC9811, IC9838, IC9894, IC9923, IC9925, IC9926, IC9927, IC9928, IC9929, IC9930, IC9931; 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK; UDI-DI: 00813502012484; Serial Numbers: IC10008, IC10011, IC10025, IC10240, IC10241, IC10592, IC10593, IC10598, IC10601, IC11196, IC11197, IC11198, IC11640, IC11642, IC11645, IC11646, IC12714, IC12717, IC12725, IC12727, IC12728, IC9990, IC12255, IC10164, IC10165, IC12315, IC12318, IC12561, IC12563, IC12726, IC13338, IC10224, IC10225, IC10788, IC10789, IC10790, IC10792, IC10793, IC11723, IC11724, IC12256, IC12716, IC12718, IC13235, IC11682, IC11683; 6. Optical, AIC, I...

Label field

Details supplied by the agency

Lot, code or applicability

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, IC9051, IC9052, IC9072, IC9076, IC9077, IC9078, IC9106, IC9107, IC9108, IC9109, IC9110, IC9111, IC9112, IC9113, IC9114, IC9115, IC9169, IC9171, IC9176, IC9216, IC9217, IC9251, IC9253, IC9257, IC9260, IC9342, IC9345, IC9352, IC9424, IC9427, IC9762, IC9763, IC9764, IC9765, IC9766, IC9824, IC9945, IC9948, IC13709, IC13710, IC13711, IC13712, IC10123, IC10124, IC10127, IC10138, IC10140, IC10141, IC10142, IC10143, IC10144, IC10148, IC10152, IC10155, IC10157, IC10158, IC10161, IC10166, IC10173, IC10176, IC10256, IC10257, IC10258, IC10259, IC10260, IC10261, IC10262, IC10263, IC10264, IC10265, IC10329, IC10347, IC10370, IC10389, IC10393, IC10395, IC10398, IC10401, IC10404, IC10408, IC10415, IC10416, IC10423, IC10424, IC10425, IC10433, IC10434, IC10437, IC10438, IC10439, IC10440, IC10442, IC10468, IC10506, IC10510, IC10542, IC10543, IC10552, IC10591, IC10621, IC10633, IC10634, IC10635, IC10636, IC10638, IC10720, IC10738, IC10767, IC10768, IC10778, IC10781, IC10819, IC10858, IC10870, IC10883, IC10884, IC10898, IC10909, IC10917, IC10919, IC10939, IC10943, IC10944, IC10945, IC10947, IC10948, IC10949, IC10953, IC10954, IC10955, IC11003, IC11004, IC11005, IC11009, IC11095, IC11120, IC11122, IC11124, IC11127, IC11133, IC11136, IC11137, IC11141, IC11142, IC11149, IC11193, IC11209, IC11214, IC11224, IC11225, IC11226, IC11228, IC11233, IC11235, IC11277, IC11278, IC11279, IC11280, IC11286, IC11287, IC11288, IC11322, IC11328, IC11332, IC11334, IC11360, IC11361, IC11364, IC11367, IC11699, IC11705, IC11707, IC11708, IC11709, IC11710, IC11711, IC11900, IC11909, IC11928, IC11929, IC11934, IC11937, IC11942, IC11943, IC11946, IC11947, IC11950, IC11953, IC11954, IC11956, IC11957, IC11962, IC11963, IC11971, IC11975, IC11977, IC11981, IC11984, IC11985, IC11987, IC11988, IC11993, IC11995, IC12002, IC12014, IC12208, IC12212, IC12219, IC12222, IC12223, IC12271, IC12275, IC12280, IC12287, IC12289, IC12291, IC12308, IC12312, IC12313, IC12320, IC12442, IC12451, IC12453, IC12464, IC12470, IC12487, IC12493, IC12495, IC12523, IC12536, IC12538, IC12541, IC12550, IC12554, IC12556, IC12558, IC12567, IC12568, IC12574, IC12575, IC12585, IC12590, IC12591, IC12597, IC12640, IC12648, IC12667, IC12668, IC12673, IC12751, IC12759, IC12760, IC12763, IC12805, IC12807, IC12811, IC12821, IC12827, IC12829, IC12833, IC12834, IC12854, IC12865, IC12939, IC12940, IC12941, IC12944, IC12946, IC12947, IC12948, IC13003, IC13026, IC13036, IC13081, IC13097, IC13098, IC13100, IC13101, IC13103, IC13104, IC13105, IC13106, IC13107, IC13119, IC13137, IC13178, IC13183, IC13186, IC13292, IC13295, IC13296, IC13318, IC13319, IC13321, IC13332, IC13353, IC13355, IC13359, IC13367, IC13369, IC13370, IC13374, IC13731, IC13741, IC13751, IC13752, IC13762, IC13775, IC13777, IC13778, IC13779, IC13780, IC13806, IC8818, IC8819, IC8820, IC8824, IC8827, IC8836, IC8837, IC8838, IC8839, IC8841, IC8842, IC8865, IC8866, IC8868, IC8869, IC8870, IC8871, IC8872, IC8873, IC8874, IC8876, IC8898, IC8899, IC8900, IC8901, IC8902, IC8910, IC8911, IC8912, IC8913, IC8914, IC9000A, IC9001A, IC9003A, IC9004A, IC9009, IC9012, IC9013, IC9014, IC9016, IC9017, IC9019, IC9020, IC9021, IC9022, IC9039, IC9050, IC9069, IC9070, IC9075, IC9167, IC9168, IC9170, IC9172, IC9173, IC9174, IC9175, IC9179, IC9180, IC9189, IC9190, IC9191, IC9193, IC9194, IC9215, IC9254, IC9255, IC9256, IC9258, IC9259, IC9281, IC9330, IC9343, IC9389, IC9396, IC9398, IC9401, IC9425, IC9426, IC9429, IC9552, IC9553, IC9554, IC9555, IC9556, IC9643, IC9687, IC9689, IC9692, IC9693, IC9758, IC9760, IC9828, IC9868, IC9942, IC9944, IC9951, IC9954, IC9955, IC9956, IC9957, IC9958, IC9960, IC9966, IC9967, IC9968, IC12826, IC12831, IC13629, IC13647, IC9192, IC10560, IC10590, IC10698, IC10706, IC10773, IC10775, IC10799, IC10820, IC10885, IC10886, IC10890, IC10891, IC10892, IC10916, IC10920, IC10921, IC10940, IC10942, IC10946, IC10951, IC11074, IC11121, IC11229, IC11240, IC11302, IC11366, IC11714, IC11716, IC11914, IC11915, IC11964, IC11965, IC11968, IC11998, IC12000, IC12215, IC12218, IC12284, IC12288, IC12443, IC12444, IC12445, IC12452, IC12545, IC12552, IC12587, IC12762, IC12803, IC12815, IC12931, IC13017, IC13024, IC13091, IC13092, IC13099, IC13108, IC13109, IC13187, IC13294, IC9420, IC9428, IC9430, IC9431, IC9690, IC9827, IC9962, IC9964, IC10125, IC10156, IC10167, IC10168, IC10172, IC10183, IC10950, IC11999, IC12278, IC12480, IC12543, IC12766, IC12830, IC12933, IC13191, IC13247, IC13320, IC13356, IC13113, IC13127, IC13180, IC13193, IC10402, IC10403, IC10441, IC10505, IC10507, IC10508, IC10675, IC10676, IC12801, IC12808, IC9399, IC9402, IC9623, IC9626, IC9644, IC9645, IC9647, IC10153, IC10160, IC10580, IC10629, IC10887, IC10889, IC11006, IC11321, IC11323, IC11324, IC11326, IC11330, IC11331, IC11726, IC12013, IC12224, IC12549, IC12649, IC12786, IC12988, IC13020, IC13102, IC13132, IC13181, IC13184, IC9403, IC9404, IC9624, IC9646, IC9896, IC9946, IC9728, IC13142, IC13143, IC13144, IC13146, IC13148, IC13150, IC13151, IC13156, IC13157, IC13158; 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP; UDI-DI: 00813502011814; Serial Numbers: IC10016, IC10018, IC10019, IC10020, IC10021, IC10022, IC10068, IC10107, IC10119, IC10120, IC10272, IC10273, IC10274, IC10275, IC10276, IC10280, IC10290, IC10354, IC10355, IC10356, IC10357, IC10359, IC10363, IC10368, IC10405, IC10409, IC10413, IC10426, IC10427, IC10503, IC10504, IC10536, IC10537, IC10538, IC10539, IC10563, IC10583, IC10699, IC10700, IC10705, IC10806, IC10807, IC10810, IC10869, IC10906, IC10907, IC10928, IC10930, IC10931, IC10932, IC11088, IC11192, IC11195, IC11218, IC11253, IC11339, IC11340, IC11370, IC11376, IC11378, IC11405, IC11417, IC11453, IC11454, IC11459, IC11499, IC11570, IC11623, IC11636, IC11666, IC11672, IC11678, IC11687, IC11689, IC11690, IC11694, IC11720, IC11725, IC11727, IC11738, IC11743, IC11750, IC11751, IC11777, IC11778, IC12026, IC12028, IC12029, IC12030, IC12031, IC12404, IC12405, IC12434, IC12437, IC12438, IC12515, IC12516, IC12517, IC12518, IC12609, IC12610, IC12612, IC12613, IC12614, IC12617, IC12618, IC12619, IC12620, IC12752, IC12769, IC12775, IC12776, IC12841, IC12843, IC12846, IC12849, IC12852, IC12853, IC13258, IC13259, IC13324, IC13326, IC13392, IC13393, IC8196, IC8197, IC8237, IC8238, IC8239, IC8240, IC8241, IC8245, IC8246, IC8298, IC8299, IC8301, IC8302, IC8303, IC8304, IC8306, IC8309, IC8310, IC8364, IC8369, IC8370, IC8371, IC8372, IC8374, IC8375, IC8491, IC8492, IC8523, IC8524, IC8526, IC8531, IC8571, IC8573, IC8583, IC8595, IC8597, IC8599, IC8601, IC8619, IC8626, IC8666, IC8670, IC8679, IC8680, IC8681, IC8682, IC8684, IC8685, IC8687, IC8731, IC8732, IC8733, IC8734, IC8735, IC8779, IC8780, IC8782, IC8784, IC8785, IC8886, IC8887, IC8888, IC8889, IC8890, IC8892, IC8893, IC8894, IC8896, IC8897, IC8915, IC8916, IC8917, IC8918, IC8919, IC8921, IC8922, IC8923, IC8924, IC8927, IC8937, IC9125, IC9126, IC9127, IC9128, IC9129, IC9130, IC9131, IC9132, IC9134, IC9135, IC9136, IC9137, IC9138, IC9139, IC9140, IC9288, IC9289, IC9290, IC9291, IC9292, IC9294, IC9295, IC9298, IC9321, IC9322, IC9323, IC9325, IC9326, IC9329, IC9331, IC9332, IC9411, IC9462, IC9463, IC9485, IC9489, IC9490, IC9491, IC9492, IC9494, IC9495, IC9496, IC9497, IC9498, IC9499, IC9540, IC9559, IC9560, IC9561, IC9562, IC9563, IC9580, IC9694, IC9702, IC9703, IC9704, IC9705, IC9707, IC9708, IC9709, IC9786, IC9787, IC9790, IC9791, IC9811, IC9838, IC9894, IC9923, IC9925, IC9926, IC9927, IC9928, IC9929, IC9930, IC9931; 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK; UDI-DI: 00813502012484; Serial Numbers: IC10008, IC10011, IC10025, IC10240, IC10241, IC10592, IC10593, IC10598, IC10601, IC11196, IC11197, IC11198, IC11640, IC11642, IC11645, IC11646, IC12714, IC12717, IC12725, IC12727, IC12728, IC9990, IC12255, IC10164, IC10165, IC12315, IC12318, IC12561, IC12563, IC12726, IC13338, IC10224, IC10225, IC10788, IC10789, IC10790, IC10792, IC10793, IC11723, IC11724, IC12256, IC12716, IC12718, IC13235, IC11682, IC11683; 6. Optical, AIC, I...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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;

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Dates in the source

Report date: Sep 23, 2026
Recall initiation date: Aug 12, 2026
Center classification date: Sep 16, 2026

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Lot and product identifiers

Distribution

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