Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella C

Summary

The FDA issued a Class II for Automated Impella Controller (AIC) with the below product descriptions and corre by Abiomed, Inc.. Reason: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected t.

Details

Product Description

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 7. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Lot/Code Info: 1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Number: IC2687. 2. Product Code: 0042-0000-EU. GTIN: 00813502011289. Serial Numbers: IC3875, IC2380, IC2331, IC1721, IC1593, IC1587, IC4911, IC4231, IC4232, IC6844, IC2221, IC4628, IC6474, IC4502, IC1398, IC4055, IC3816, IC6810, IC6812, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6272, IC6149, IC6081, IC5681, IC5682, IC5517, IC5177, IC5169, IC5086, IC4892, IC4852, IC4848, IC4875, IC4851, IC4869, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4793, IC4795, IC4792, IC4794, IC4763, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4678, IC4677, IC4646, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4613, IC4614, IC4568, IC4610, IC4612, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4505, IC4506, IC4500, IC4469, IC4466, IC4467, IC4468, IC4446, IC4442, IC4443, IC4444, IC4445, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4328, IC4234, IC4363, IC4362, IC4356, IC4357, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4240, IC4241, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4217, IC4148, IC4149, IC4146, IC4147, IC4128, IC4129, IC4096, IC4097, IC4098, IC4083, IC4036, IC4037, IC3889, IC3833, IC3834, IC3859, IC3861, IC3862, IC3863, IC3885, IC3886, IC3884, IC3871, IC3872, IC3873, IC3832, IC3860, IC3831, IC3830, IC3815, IC3813, IC3814, IC3781, IC3782, IC3708, IC3717, IC3706, IC3707, IC3701, IC3703, IC3709, IC3667, IC3495, IC3492, IC3493, IC3659, IC3490, IC3660, IC3484, IC3485, IC3477, IC3472, IC3461, IC3467, IC3466, IC3468, IC3458, IC3459, IC3330, IC3460, IC3323, IC3313, IC3319, IC3327, IC3328, IC3303, IC3324, IC3321, IC3322, IC3310, IC3315, IC3314, IC3316, IC3304, IC3305, IC3302, IC3301, IC3300, IC3299, IC3297, IC3298, IC3290, IC3292, IC3289, IC3286, IC3288, IC3287, IC3180, IC3181, IC3178, IC3179, IC3145, IC3146, IC3144, IC3143, IC3149, IC3147, IC3148, IC3142, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3095, IC3096, IC3068, IC3067, IC3053, IC3054, IC3051, IC3052, IC3019, IC3017, IC2988, IC2987, IC2984, IC2985, IC2878, IC2960, IC2962, IC2964, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2824, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2708, IC2752, IC2670, IC2659, IC2658, IC2512, IC2556, IC2534, IC2491, IC2484, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2332, IC2412, IC2330, IC2411, IC2326, IC2327, IC2242, IC2325, IC2267, IC2268, IC2241, IC2266, IC2243, IC2204, IC2207, IC2240, IC2231, IC2173, IC2174, IC2171, IC2172, IC2095, IC2098, IC2096, IC2038, IC2039, IC2005, IC2006, IC1975, IC1976, IC1972, IC1973, IC1904, IC1907, IC1901, IC1881, IC1775, IC1780, IC1726, IC1761, IC1653, IC1411, IC1350, IC1383, IC1344, IC1345, IC1288, IC1275, IC1265. 3. Product Code: 0042-0000-UK. GTIN: 00813502011296. Serial Numbers: IC1494, IC3785, IC3784. 4. Product Code: 0042-0000-US. GTIN: 00813502010022. Serial Numbers: IC7027, IC7030, IC7032, IC6931, IC6930, IC6932, IC6929, IC6928, IC6923, IC6919, IC6920, IC6921, IC6922, IC6898, IC6897, IC6917, IC6916, IC6889, IC6894, IC6895, IC6893, IC6901, IC6909, IC6911, IC6910, IC6912, IC6908, IC6913, IC6896, IC6899, IC6900, IC6842, IC6840, IC6836, IC6829, IC6831, IC6832, IC6811, IC6774, IC6864, IC6830, IC6801, IC6800, IC6798, IC6799, IC6847, IC6771, IC6772, IC6850, IC6851, IC6852, IC6854, IC6822, IC6820, IC6819, IC6818, IC6767, IC6754, IC6743, IC6729, IC6725, IC6724, IC6722, IC6682, IC6679, IC6685, IC6674, IC6668, IC6667, IC6647, IC6645, IC6646, IC6639, IC6630, IC6624, IC6625, IC6619, IC6616, IC6613, IC6612, IC6602, IC6601, IC6600, IC6571, IC6568, IC6566, IC6567, IC6565, IC6562, IC6547, IC6546, IC6524, IC6522, IC6518, IC6521, IC6514, IC6511, IC6505, IC6507, IC6504, IC6500, IC6501, IC6497, IC6498, IC6448, IC6495, IC6496, IC6428, IC6445, IC6484, IC6483, IC6438, IC6433, IC6479, IC6471, IC6472, IC6473, IC6470, IC6455, IC6454, IC6427, IC6426, IC6444, IC6450, IC6415, IC6412, IC6414, IC6411, IC6408, IC6409, IC6410, IC6404, IC6403, IC6402, IC6400, IC6401, IC6398, IC6399, IC6045, IC6391, IC6396, IC6392, IC6390, IC6393, IC6394, IC6361, IC6362, IC6368, IC6366, IC6367, IC6369, IC6365, IC6363, IC6364, IC6355, IC6356, IC6295, IC6288, IC6354, IC6352, IC6353, IC6349, IC6335, IC6346, IC6328, IC6329, IC6326, IC6327, IC6325, IC6323, IC6324, IC6319, IC6320, IC6317, IC6318, IC1250, IC6095, IC6271, IC6269, IC6255, IC6266, IC6267, IC6251, IC6250, IC6247, IC6248, IC6249, IC6244, IC6245, IC6246, IC6243, IC6242, IC6241, IC6239, IC6220, IC6218, IC6219, IC6217, IC6198, IC6199, IC6195, IC6196, IC6194, IC6192, IC6190, IC6191, IC6186, IC6187, IC6188, IC6189, IC6184, IC6185, IC6182, IC6183, IC6180, IC6181, IC6179, IC6177, IC6178, IC6176, IC6156, IC6161, IC6159, IC6160, IC6157, IC6158, IC6155, IC6154, IC6153, IC6152, IC6141, IC6144, IC6145, IC6146, IC6143, IC6133, IC6134, IC6136, IC6142, IC6140, IC6115, IC5565, IC6138, IC6137, IC6135, IC6129, IC6130, IC6131, IC6132, IC6128, IC6105, IC6106, IC6107, IC6103, IC6104, IC6100, IC6101, IC6102, IC6099, IC6097, IC6098, IC6092, IC6093, IC6094, IC6096, IC6077, IC6059, IC6063, IC6062, IC6061, IC6056, IC6057, IC6054, IC6055, IC6053, IC6051, IC6052, IC6041, IC6043, IC6044, IC6039, IC6040, IC6035, IC6036, IC6037, IC6034, IC6000, IC6031, IC6032, IC6028, IC6030, IC6033, IC6026, IC6027, IC6002, IC6003, IC6004, IC5992, IC5994, IC5985, IC5986, IC5987, IC5988, IC5989, IC5990, IC5981, IC5982, IC5979, IC5977, IC5978, IC5976, IC5954, IC5953, IC5952, IC5951, IC5950, IC5949, IC5947, IC5948, IC5946, IC5945, IC5943, IC5939, IC5940, IC5942, IC5906, IC5895, IC5893, IC5891, IC5892, IC5894, IC5890, IC5843, IC5889, IC5888, IC5881, IC5882, IC5883, IC5886, IC5887, IC5884, IC5885, IC5880, IC5778, IC5599, IC5776, IC5879, IC5874, IC5872, IC5873, IC5875, IC5878, IC5876, IC5877, IC5871, IC5870, IC5858, IC5855, IC5856, IC5857, IC5852, IC5848, IC5849, IC5850, IC5851, IC5847, IC5844, IC5845, IC5839, IC5840, IC5841, IC5842, IC5816, IC5827, IC5828, IC5823, IC5792, IC5793, IC5791, IC5790, IC5789, IC5787, IC5773, IC5770, IC5767, IC5766, IC5765, IC5763, IC5764, IC5760, IC5761, IC5747, IC5745, IC5746, IC5742, IC5743, IC5737, IC5738, IC5739, IC5736, IC5726, IC5723, IC5719, IC5711, IC5710, IC5707, IC5708, IC5704, IC5698, IC5697, IC5692, IC5691, IC5598, IC5663, IC5664, IC5676, IC5678, IC5619, IC5620, IC5564, IC5607, IC5650, IC5655, IC5647, IC5617, IC5615, IC5602, IC5562, IC5610, IC5604, IC5244, IC5552, IC5547, IC5548, IC5544, IC5540, IC5541, IC5539, IC5536, IC4556, IC5498, IC5499, IC5500, IC5503, IC5485, IC5480, IC5479, IC5475, IC4888, IC4889, IC4697, IC4573, IC4517, IC5469, IC5459, IC5470, IC5458, IC5457, IC4558, IC4498, IC4854, IC4935, IC5454, IC5092, IC4481, IC5453, IC5425, IC5420, IC4424, IC5395, IC5394, IC5417, IC5393, IC4584, IC5388, IC4554, IC4515, IC4426, IC5386, IC4922, IC4923, IC4827, IC5375, IC4427, IC4428, IC5374, IC4555, IC5373, IC5372, IC4862, IC4863, IC4574, IC4545, IC5371, IC4510, IC5003, IC4785, IC4786, IC4532, IC5365, IC5366, IC5367, IC5368, IC5369, IC5364, IC4544, IC4541, IC4686, IC4282, IC5345, IC5358, IC5359, IC5360, IC5361, IC5362, IC5363, IC4513, IC4283, IC5342, IC5343, IC5344, IC5340, IC5339, IC4477, IC5338, IC4550, IC4456, IC4415, IC4487, IC4423, IC4495, IC4378, IC4534, IC5337, IC4522, IC4486, IC4494, IC4461, IC4454, IC4431, IC4435, IC4436, IC4379, IC5336, IC5330, IC5335, IC5327, IC5328, IC5332, IC5329, IC5333, IC5334, IC4530, IC4453, IC4422, IC5320, IC5325, IC5324, IC5326, IC5322, IC5323, IC5321, IC4420, IC4336, IC5319, IC5318, IC4535, IC4490, IC4473, IC5313, IC5316, IC5317, IC5311, IC5312, IC5305, IC5304, IC5308, IC5306, IC5242, IC5303, IC5307, IC5310, IC5309, IC5299, IC5300, IC5301, IC5302, IC4472, IC4430, IC4434, IC5271, IC5297, IC5298, IC5293, IC5295, IC5296, IC4694, IC4543, IC4489, IC4474, IC5289, IC5287, IC5288, IC5275, IC5274, IC4526, IC5270, IC5269, IC5272, IC5273, IC4523, IC5266, IC5264, IC5265, IC5267, IC5268, IC4552, IC4540, IC4524, IC4520, IC4476, IC4455, IC4920, IC4804, IC4596, IC4539, IC4509, IC4460, IC5262, IC5263, IC4921, IC4458, IC4974, IC4980, IC4903, IC4485, IC4459, IC4457, IC5221, IC5222, IC5225, IC5172, IC5206, IC5170, IC5192, IC4981, IC4975, IC4696, IC4661, IC4665, IC4604, IC4551, IC4480, IC4432, IC4267, IC5190, IC5191, IC4899, IC4670, IC4536, IC4463, IC3644, IC3592, IC3594, IC4399, IC4408, IC4407, IC4403, IC3825, IC3350, IC3170, IC2869, IC2631, IC2634, IC2465, IC2487, IC1802, IC1830, IC1812, IC1425, IC3923, IC3254, IC2569, IC2580, IC1426, IC1261, IC5188, IC5189, IC4409, IC4402, IC4401, IC4274, IC3792, IC3348, IC3275, IC2781, IC2590, IC2579, IC2516, IC2075, IC1864, IC1814, IC1789, IC1705, IC1674, IC1431, IC1196, IC4828, IC4826, IC4499, IC5208, IC5209, IC3336, IC3272, IC3219, IC3250, IC2870, IC5204, IC5203, IC5207, IC5205, IC4970, IC4977, IC4900, IC4811, IC4674, IC4538, IC3117, IC1756, IC1704, IC4496, IC4497, IC5202, IC5200, IC5198, IC5199, IC5196, IC5197, IC5168, IC5150, IC5166, IC5167, IC5024, IC5155, IC5153, IC5154, IC5151, IC5152, IC5148, IC5149, IC5052, IC5124, IC5125, IC5146, IC5147, IC5123, IC5119, IC5093, IC5094, IC5122, IC5095, IC5116, IC5090, IC5070, IC5072, IC5091, IC5069, IC5063, IC5059, IC5060, IC5054, IC5058, IC4807, IC5074, IC5067, IC5062, IC5061, IC5017, IC5018, IC5005, IC5002, IC4999, IC5019, IC4997, IC4998, IC4994, IC4993, IC4991, IC4990, IC4989, IC4982, IC4475, IC4575, IC4972, IC4969, IC4983, IC4978, IC4979, IC4956, IC4971, IC4967, IC4964, IC4966, IC4962, IC4963, IC4941, IC4943, IC4940, IC4942, IC4938, IC4939, IC4936, IC4937, IC4924, IC4925, IC4918, IC4919, IC4906, IC4907, IC4908, IC4909, IC4904, IC4905, IC4519, IC4902, IC4245, IC4898, IC4896, IC4897, IC4894, IC4895, IC4893, IC4890, IC4886, IC4887, IC4861, IC4884, IC4885, IC4865, IC4864, IC4859, IC4860, IC4858, IC4829, IC4830, IC4825, IC4814, IC4812, IC4813, IC4805, IC4806, IC4802, IC4803, IC4808, IC4809, IC4799, IC4798, IC4789, IC4788, IC4770, IC4769, IC4768, IC4766, IC4767, IC4764, IC4765, IC4755, IC4756, IC4754, IC4752, IC4753, IC4719, IC4720, IC4702, IC4698, IC4699, IC4692, IC4695, IC4693, IC4684, IC4685, IC4668, IC4666, IC4662, IC4660, IC4639, IC4638, IC4603, IC4580, IC4571, IC4593, IC4548, IC4546, IC4547, IC4527, IC4531, IC4529, IC4521, IC4511, IC4512, IC4491, IC4492, IC4483, IC4484, IC4479, IC4493, IC4478, IC4462, IC4437, IC4433, IC4416, IC4417, IC4414, IC4413, IC4411, IC4412, IC4410, IC4390, IC4406, IC4400, IC4398, IC4395, IC4396, IC4392, IC4391, IC4389, IC4386, IC4387, IC4381, IC4382, IC4383, IC4380, IC4376, IC4375, IC4377, IC4373, IC4374, IC4372, IC4351, IC4352, IC4353, IC4354, IC4350, IC4349, IC4348, IC4346, IC4347, IC4345, IC4344, IC4341, IC4342, IC4343, IC4340, IC4339, IC4337, IC4333, IC4320, IC4321, IC4317, IC4318, IC4314, IC4313, IC4311, IC4312, IC4309, IC4310, IC4306, IC4305, IC4304, IC4302, IC4303, IC4301, IC4300, IC4299, IC4298, IC4297, IC4295, IC4293, IC4294, IC4290, IC4291, IC4284, IC4285, IC4280, IC4281, IC4279, IC4278, IC4276, IC4275, IC4273, IC4270, IC4271, IC4263, IC4269, IC4268, IC4265, IC4266, IC4262, IC4264, IC4260, IC4261, IC4259, IC4250, IC4248, IC4247, IC4249, IC4246, IC4243, IC4244, IC4225, IC4226, IC4223, IC4224, IC4221, IC4222, IC4219, IC4220, IC4203, IC4204, IC4205, IC4206, IC4201, IC4202, IC4200, IC4198, IC4196, IC4197, IC4194, IC4195, IC4192, IC4191, IC4174, IC4172, IC4173, IC4170, IC4171, IC4169, IC4167, IC4168, IC4165, IC4163, IC4164, IC4159, IC4136, IC4111, IC4115, IC4112, IC4113, IC4103, IC4104, IC4084, IC4085, IC4076, IC4071, IC4072, IC4073, IC4040, IC4038, IC4039, IC4030, IC4031, IC4029, IC4020, IC4021, IC4016, IC4011, IC4008, IC4005, IC4003, IC3998, IC3999, IC3997, IC4000, IC4001, IC3995, IC3996, IC3994, IC3993, IC3990, IC3986, IC3984, IC3982, IC3985, IC3987, IC3983, IC3980, IC3981, IC3979, IC3973, IC3974, IC3971, IC3972, IC3969, IC3970, IC3899, IC3968, IC3966, IC3967, IC3963, IC3962, IC3960, IC3959, IC3957, IC3958, IC3865, IC3954, IC3955, IC3956, IC3952, IC3953, IC3950, IC3951, IC3948, IC3949, IC3947, IC3946, IC3945, IC3940, IC3944, IC3943, IC3941, IC3942, IC3939, IC3937, IC3938, IC3935, IC3933, IC3934, IC3931, IC3932, IC3928, IC3926, IC3927, IC3929, IC3930, IC3924, IC3925, IC3919, IC3920, IC3915, IC3916, IC3917, IC3918, IC3913, IC3914, IC3912, IC3909, IC3910, IC3911, IC3907, IC3908, IC3906, IC3904, IC3902, IC3903, IC3900, IC3901, IC3897, IC3898, IC3895, IC3896, IC3893, IC3894, IC3892, IC3883, IC3879, IC3880, IC3881, IC3882, IC3876, IC3877, IC3878, IC3858, IC3854, IC3855, IC3856, IC3857, IC3852, IC3853, IC3851, IC3850, IC3849, IC3848, IC3846, IC3847, IC3838, IC3839, IC3835, IC3826, IC3820, IC3821, IC3819, IC3811, IC3808, IC3809, IC3807, IC3804, IC3799, IC3800, IC3801, IC3798, IC3796, IC3797, IC3794, IC3795, IC3793, IC3791, IC3790, IC3787, IC3788, IC3789, IC3774, IC3775, IC3772, IC3773, IC3770, IC3771, IC3768, IC3769, IC3753, IC3754, IC3752, IC3750, IC3749, IC3748, IC3746, IC3747, IC3741, IC3744, IC3745, IC3742, IC3743, IC3740, IC3736, IC3737, IC3738, IC3739, IC3735, IC3734, IC3733, IC3729, IC3730, IC3732, IC3725, IC3726, IC3727, IC3728, IC3714, IC3715, IC3712, IC3713, IC3694, IC3695, IC3710, IC3711, IC3693, IC3690, IC3688, IC3685, IC3680, IC3681, IC3679, IC3650, IC3649, IC3647, IC3648, IC3645, IC3646, IC3643, IC3641, IC3642, IC3638, IC3636, IC3637, IC3635, IC3634, IC3632, IC3633, IC3628, IC3629, IC3627, IC3626, IC3564, IC3610, IC3622, IC3623, IC3624, IC3625, IC3603, IC3601, IC3602, IC3599, IC3600, IC3595, IC3596, IC3529, IC3589, IC3590, IC3581, IC3582, IC3609, IC3579, IC3580, IC3577, IC3578, IC3574, IC3572, IC3567, IC3568, IC3561, IC3557, IC3547, IC3548, IC3544, IC3542, IC3530, IC3528, IC3516, IC3517, IC3520, IC3521, IC3507, IC3508, IC3504, IC3505, IC3506, IC3502, IC3503, IC3499, IC3446, IC3447, IC3443, IC3444, IC3439, IC3437, IC3438, IC3434, IC3432, IC3428, IC3427, IC3426, IC3421, IC3422, IC3419, IC3415, IC3416, IC3417, IC3418, IC3410, IC3411, IC3408, IC3409, IC3406, IC3407, IC3378, IC3379, IC3404, IC3405, IC3354, IC3401, IC3399, IC3400, IC3394, IC3396, IC3397, IC3346, IC3284, IC3386, IC3388, IC3390, IC3384, IC3385, IC3380, IC3381, IC3382, IC3383, IC3371, IC3372, IC3373, IC3283, IC3285, IC3269, IC3369, IC3370, IC3376, IC3377, IC3374, IC3375, IC3367, IC3368, IC3366, IC3361, IC3362, IC3365, IC3363, IC3364, IC3358, IC3359, IC3360, IC3357, IC3355, IC3356, IC3352, IC3353, IC3345, IC3343, IC3337, IC3338, IC3339, IC3340, IC3281, IC3282, IC3341, IC3278, IC3279, IC3277, IC3274, IC3276, IC3270, IC3065, IC3066, IC3271, IC3273, IC3064, IC3268, IC3267, IC3263, IC3266, IC3262, IC3261, IC3257, IC3259, IC3260, IC3258, IC3253, IC3255, IC3215, IC3216, IC3214, IC3217, IC3221, IC3222, IC3218, IC3220, IC3169, IC3185, IC3171, IC3172, IC3176, IC3177, IC3249, IC3251, IC3252, IC3168, IC3248, IC3246, IC3245, IC3247, IC3244, IC3242, IC3243, IC3237, IC3238, IC3239, IC3236, IC3235, IC3233, IC3234, IC3229, IC3230, IC3231, IC3232, IC3224, IC3225, IC3226, IC3212, IC3227, IC3228, IC3207, IC3208, IC3209, IC3211, IC3204, IC3205, IC3206, IC3201, IC3202, IC3203, IC3199, IC3200, IC3198, IC3196, IC3197, IC3193, IC3194, IC3188, IC3189, IC3192, IC3186, IC3187, IC3163, IC3162, IC3164, IC3165, IC3158, IC3159, IC3156, IC3157, IC3152, IC3153, IC3151, IC3139, IC3136, IC3137, IC2978, IC3135, IC3125, IC3126, IC3121, IC3122, IC3123, IC3119, IC3111, IC3113, IC3114, IC3115, IC3118, IC3110, IC3109, IC3108, IC3105, IC3106, IC3103, IC3104, IC3091, IC3092, IC3093, IC3094, IC3089, IC3090, IC3087, IC3086, IC3083, IC3084, IC3085, IC3082, IC2928, IC2791, IC2499, IC3079, IC3080, IC3077, IC3078, IC3075, IC3076, IC3071, IC3072, IC3073, IC3074, IC3062, IC3060, IC3061, IC3058, IC3059, IC3056, IC3055, IC3046, IC3044, IC3045, IC3042, IC3040, IC3041, IC3039, IC3038, IC3036, IC3034, IC3032, IC3033, IC3031, IC3028, IC3029, IC3026, IC3027, IC3030, IC3024, IC3025, IC3023, IC3013, IC3007, IC3008, IC3009, IC3010, IC3006, IC3005, IC3003, IC3004, IC3001, IC3002, IC2999, IC3000, IC2998, IC2995, IC2992, IC2994, IC2990, IC2991, IC2983, IC2993, IC2979, IC2980, IC2974, IC2975, IC2976, IC2977, IC2973, IC2972, IC2969, IC2970, IC2965, IC2966, IC2955, IC2956, IC2951, IC2952, IC2945, IC2946, IC2947, IC2948, IC2731, IC2940, IC2936, IC2937, IC2924, IC2922, IC2926, IC2918, IC2919, IC2920, IC2917, IC2915, IC2916, IC2749, IC2907, IC2901, IC2898, IC2889, IC2885, IC2886, IC2883, IC2881, IC2882, IC2868, IC2865, IC2866, IC2863, IC2848, IC2844, IC2845, IC2832, IC2833, IC2813, IC2822, IC2807, IC2821, IC2819, IC2820, IC2795, IC2796, IC2792, IC2793, IC2794, IC2789, IC2784, IC2786, IC2787, IC2780, IC2772, IC2773, IC2768, IC2761, IC2719, IC2759, IC2760, IC2744, IC2745, IC2746, IC2742, IC2748, IC2739, IC2738, IC2727, IC2729, IC2728, IC2725, IC2726, IC2722, IC2498, IC2408, IC2410, IC2717, IC2718, IC2714, IC2715, IC2716, IC2713, IC2703, IC2700, IC2701, IC2698, IC2699, IC2694, IC2696, IC2697, IC2321, IC2120, IC2690, IC2689, IC2674, IC2681, IC2675, IC2680, IC2671, IC2672, IC2666, IC2667, IC2664, IC2665, IC2648, IC2649, IC2647, IC2646, IC2643, IC2644, IC2662, IC2663, IC2650, IC2651, IC2660, IC2661, IC2638, IC2640, IC2641, IC2636, IC2637, IC2635, IC2632, IC2633, IC2615, IC2616, IC2618, IC2619, IC2620, IC2622, IC2612, IC2613, IC2611, IC2605, IC2608, IC2603, IC2604, IC2601, IC2602, IC2600, IC2599, IC2597, IC2598, IC2217, IC2218, IC2506, IC2594, IC2595, IC2596, IC2593, IC2591, IC2592, IC2587, IC2589, IC2584, IC2581, IC2582, IC2578, IC2576, IC2577, IC2574, IC2572, IC2573, IC2570, IC2567, IC2568, IC2563, IC2564, IC2555, IC2554, IC2552, IC2553, IC2551, IC2524, IC2550, IC2548, IC2543, IC2544, IC2468, IC2495, IC2480, IC2482, IC2539, IC2540, IC2538, IC2537, IC2532, IC2533, IC2529, IC2530, IC2531, IC2522, IC2520, IC2521, IC2517, IC2518, IC2523, IC2525, IC2466, IC2528, IC2527, IC2464, IC2515, IC2507, IC2513, IC2514, IC2508, IC2509, IC2510, IC2511, IC2504, IC2502, IC2500, IC2489, IC2467, IC2488, IC2462, IC2463, IC2439, IC2458, IC2436, IC2322, IC2167, IC2454, IC2456, IC2445, IC2446, IC2447, IC2438, IC2440, IC2437, IC2430, IC2432, IC2402, IC2427, IC2433, IC2421, IC2423, IC2428, IC2429, IC2425, IC2409, IC2417, IC2418, IC2419, IC2420, IC2424, IC2422, IC2416, IC2415, IC2405, IC2401, IC2403, IC2390, IC2398, IC2407, IC2406, IC2397, IC2395, IC2384, IC2385, IC2374, IC2375, IC2365, IC2366, IC2379, IC2378, IC2364, IC2394, IC2393, IC2371, IC2372, IC2388, IC2391, IC2382, IC2383, IC2381, IC2386, IC2387, IC2373, IC2363, IC2359, IC2361, IC2362, IC2354, IC2355, IC2356, IC2357, IC2358, IC2353, IC2259, IC2351, IC2352, IC2256, IC2350, IC2193, IC2348, IC2347, IC2349, IC2317, IC2279, IC2157, IC2295, IC2297, IC2339, IC2340, IC2341, IC2310, IC2343, IC2345, IC2336, IC2338, IC2323, IC2335, IC2337, IC2333, IC2319, IC2312, IC2313, IC2300, IC2309, IC2308, IC2296, IC2284, IC2289, IC2276, IC2304, IC2305, IC2306, IC2307, IC2293, IC2299, IC1794, IC2298, IC2294, IC2301, IC2290, IC2292, IC2286, IC2288, IC2281, IC2275, IC2263, IC2215, IC2213, IC2280, IC2283, IC2285, IC2291, IC2270, IC2271, IC2274, IC2272, IC2273, IC2264, IC2265, IC2248, IC2262, IC2255, IC2261, IC2254, IC2257, IC2249, IC2252, IC2250, IC2253, IC2037, IC2212, IC2238, IC2246, IC2251, IC2214, IC2196, IC2203, IC2192, IC2177, IC2195, IC2189, IC2198, IC2188, IC2237, IC2230, IC2224, IC2228, IC2229, IC2216, IC2208, IC2209, IC2210, IC2227, IC2197, IC2200, IC2194, IC2190, IC2191, IC2182, IC2163, IC2165, IC2158, IC2159, IC2162, IC2161, IC2152, IC2153, IC2166, IC2149, IC2150, IC2138, IC1970, IC2142, IC2134, IC2136, IC2128, IC2129, IC2116, IC2117, IC1947, IC2140, IC2135, IC2139, IC2122, IC2121, IC2137, IC2141, IC1932, IC2103, IC2131, IC2132, IC2119, IC2104, IC2106, IC2107, IC2110, IC2130, IC2127, IC2108, IC2109, IC2087, IC2088, IC2111, IC2112, IC2113, IC1988, IC1983, IC2091, IC2094, IC2067, IC2056, IC2059, IC2047, IC2092, IC2093, IC2089, IC2090, IC2066, IC2022, IC2064, IC2065, IC2058, IC2057, IC2073, IC2083, IC2084, IC2081, IC2086, IC2069, IC2060, IC2050, IC2055, IC2061, IC2048, IC2052, IC2054, IC2053, IC2042, IC2044, IC2041, IC2046, IC2043, IC2045, IC2030, IC2014, IC1934, IC2004, IC2026, IC2027, IC2013, IC2015, IC2016, IC2017, IC2018, IC1989, IC1993, IC1998, IC1999, IC1997, IC1995, IC2000, IC2003, IC1979, IC1980, IC1915, IC1984, IC1985, IC1986, IC1959, IC1857, IC1968, IC1966, IC1963, IC1957, IC1958, IC1951, IC1954, IC1892, IC1967, IC1969, IC1950, IC1952, IC1953, IC1955, IC1946, IC1964, IC1965, IC1929, IC1895, IC1895, IC1860, IC1854, IC1931, IC1921, IC1923, IC1925, IC1930, IC1942, IC1943, IC1919, IC1920, IC1928, IC1945, IC1940, IC1941, IC1939, IC1938, IC1924, IC1937, IC1944, IC1935, IC1914, IC1916, IC1917, IC1918, IC1897, IC1900, IC1885, IC1888, IC1898, IC1899, IC1889, IC1891, IC1890, IC1893, IC1894, IC1536, IC1778, IC1843, IC1834, IC1837, IC1882, IC1883, IC1878, IC1879, IC1880, IC1884, IC1877, IC1759, IC1797, IC1859, IC1867, IC1862, IC1849, IC1844, IC1835, IC1858, IC1861, IC1850, IC1848, IC1847, IC2146, IC1827, IC1855, IC1838, IC1841, IC1829, IC1833, IC1816, IC1817, IC1776, IC1750, IC1832, IC1831, IC1828, IC1813, IC1820, IC1808, IC1818, IC1819, IC1811, IC1786, IC1805, IC1799, IC1800, IC1806, IC1807, IC1810, IC1803, IC1809, IC1801, IC1770, IC1788, IC1795, IC1773, IC1774, IC1771, IC1772, IC1784, IC1785, IC1781, IC1738, IC1755, IC1758, IC1760, IC1753, IC1754, IC1748, IC1749, IC1737, IC1734, IC1718, IC1751, IC1752, IC1742, IC1744, IC1735, IC1736, IC1739, IC1740, IC1728, IC1732, IC1733, IC1707, IC1712, IC1717, IC1711, IC1694, IC1666, IC1714, IC1709, IC1710, IC1702, IC1703, IC1698, IC1697, IC1692, IC1696, IC1687, IC1686, IC1688, IC1689, IC1690, IC1691, IC1669, IC1673, IC1672, IC1683, IC1681, IC1682, IC1679, IC1680, IC1670, IC1671, IC1675, IC1648, IC1654, IC1655, IC1660, IC1639, IC1668, IC1661, IC1662, IC1656, IC1657, IC1658, IC1659, IC1650, IC1642, IC1637, IC1638, IC1652, IC1651, IC1645, IC1646, IC1644, IC1630, IC1643, IC1641, IC1629, IC1640, IC1628, IC1635, IC1631, IC1632, IC1633, IC1634, IC1627, IC1626, IC1622, IC1623, IC1624, IC1625, IC1621, IC1557, IC1575, IC1599, IC1603, IC1604, IC1605, IC1556, IC1532, IC1507, IC1462, IC1563, IC1564, IC1550, IC1554, IC1540, IC1531, IC1533, IC1461, IC1596, IC1618, IC1606, IC1607, IC1571, IC1610, IC1570, IC1574, IC1561, IC1569, IC1612, IC1613, IC1608, IC1600, IC1617, IC1566, IC1568, IC1558, IC1559, IC1560, IC1609, IC1601, IC1602, IC1513, IC1469, IC1565, IC1552, IC1555, IC1538, IC1506, IC1551, IC1541, IC1529, IC1512, IC1412, IC1526, IC1514, IC1535, IC1530, IC1528, IC1517, IC1518, IC1496, IC1499, IC1503, IC1504, IC1498, IC1424, IC1429, IC1475, IC1473, IC1470, IC1474, IC1466, IC1467, IC1484, IC1485, IC1476, IC1453, IC1454, IC1450, IC1479, IC1483, IC1446, IC1448, IC1471, IC1472, IC1342, IC1460, IC1459, IC1364, IC1458, IC1455, IC1451, IC1452, IC1408, IC1379, IC1449, IC1406, IC1442, IC1443, IC1436, IC1437, IC1434, IC1435, IC1418, IC1422, IC1421, IC1423, IC1419, IC1420, IC1414, IC1417, IC1414, IC1417, IC1333, IC1394, IC1377, IC1403, IC1375, IC1401, IC1376, IC1410, IC1402, IC1404, IC1378, IC1374, IC1372, IC1365, IC1373, IC1360, IC1361, IC1358, IC1362, IC1363, IC1359, IC1313, IC1314, IC1353, IC1354, IC1355, IC1352, IC1336, IC1338, IC1339, IC1331, IC1337, IC1332, IC1335, IC1334, IC1291, IC1329, IC1330, IC1328, IC1310, IC1300, IC1306, IC1312, IC1309, IC1315, IC1316, IC1297, IC1296, IC1235, IC1110, IC1307, IC1311, IC1326, IC1327, IC1323, IC1320, IC1322, IC1325, IC1274, IC1289, IC1290, IC1234, IC1186, IC1144, IC1293, IC1272, IC1258, IC1295, IC1270, IC1246, IC1239, IC1292, IC1294, IC1264, IC1269, IC1251, IC1252, IC1271, IC1273, IC1262, IC1259, IC1263, IC1256, IC1257, IC1254, IC1253, IC1255, IC1244, IC1226, IC1221, IC1225, IC1240, IC1243, IC1227, IC1228, IC1230, IC1220, IC1219, IC1214, IC1233, IC1211, IC1212, IC1178, IC1237, IC1229, IC1236, IC1205, IC1206, IC1218, IC1192, IC1160, IC1100, IC1201, IC1215, IC1200, IC1193, IC1191, IC1209, IC1198, IC1199, IC1197, IC1194, IC1188, IC1153, IC1154, IC1183, IC1184, IC1168, IC1162, IC1159, IC1181, IC1176, IC1177, IC1171, IC1174, IC1175, IC1172, IC1173, IC1147, IC1145, IC1146, IC1141, IC1142, IC1165, IC1166, IC1167, IC1163, IC1164, IC1156, IC1149, IC1157, IC1158, IC1139, IC1151, IC1152, IC1133, IC1134, IC1121, IC1150, IC1123, IC1136, IC1137, IC1138, IC1135, IC1115, IC1120, IC1132, IC1111, IC1106, IC1116, IC1117, IC1119, IC1105, IC1084, IC1085, IC1104, IC1108, IC1093, IC1095, IC1083, IC1094, IC1103, IC1089, IC1088, IC1086, IC1087, IC1081, IC1082, IC1077, IC1078, IC1079, IC1058, IC1076, IC1075, IC1074, IC1072, IC1073, IC1068, IC1069, IC1064, IC1065, IC1066, IC1067, IC1060, IC1061, IC1050, IC1062, IC1047, IC1051, IC1039, IC1041, IC1030, IC1049, IC1042, IC1044, IC1052, IC1028, IC1040, IC1046, IC1043, IC1029, IC1026, IC1027, IC1025, IC1031, IC1032, IC1007, IC1008, IC1006, IC1014, IC1017, IC1015, IC1004. 5. Product Code: 0042-0010-EU. GTIN: 00813502010961. Serial Numbers: IC6118, IC6119, IC5129, IC5042, IC5919, IC5282, IC6263, IC6261, IC5580, IC5592, IC5038, IC7156, IC6779, IC6776, IC6462, IC6418, IC6379, IC6416, IC6417, IC6383, IC6384, IC6377, IC6378, IC6344, IC6305, IC6336, IC6337, IC6304, IC6303, IC6342, IC6343, IC6302, IC6297, IC6298, IC6299, IC6282, IC6283, IC6278, IC6279, IC6277, IC6260, IC6259, IC6257, IC6258, IC6235, IC6256, IC6070, IC6231, IC6232, IC6234, IC6175, IC6226, IC6168, IC6169, IC6166, IC6167, IC6122, IC6123, IC6121, IC6174, IC6019, IC6172, IC6173, IC6014, IC6015, IC6171, IC6075, IC6116, IC6117, IC6120, IC6124, IC6073, IC6074, IC6069, IC6067, IC6068, IC6024, IC6025, IC6022, IC6023, IC6020, IC6021, IC5966, IC5967, IC6016, IC6017, IC5968, IC6012, IC5924, IC5923, IC5900, IC5963, IC5964, IC5918, IC5921, IC5905, IC5916, IC5922, IC5925, IC5903, IC5902, IC5920, IC5897, IC5898, IC5813, IC5814, IC5896, IC5811, IC5812, IC5809, IC5810, IC5808, IC5807, IC5806, IC5804, IC5805, IC5802, IC5803, IC5671, IC5672, IC5668, IC5669, IC5666, IC5667, IC5644, IC5645, IC5641, IC5643, IC5639, IC5640, IC5638, IC5642, IC5595, IC5635, IC5636, IC5533, IC5567, IC5628, IC5631, IC5629, IC5630, IC5632, IC5594, IC5633, IC5634, IC5627, IC5529, IC5585, IC5586, IC5583, IC5584, IC5570, IC5571, IC5569, IC5577, IC5566, IC5526, IC5532, IC5527, IC5528, IC5530, IC5531, IC5415, IC5412, IC5413, IC5410, IC5411, IC5408, IC5383, IC5407, IC5403, IC5404, IC5401, IC5402, IC5396, IC5398, IC5397, IC5378, IC5376, IC5377, IC5355, IC5281, IC5235, IC5276, IC5277, IC5278, IC5279, IC5280, IC5283, IC5284, IC5285, IC5233, IC5234, IC5163, IC5164, IC5161, IC5162, IC5082, IC5157, IC5159, IC5160, IC5158, IC5145, IC5156, IC5140, IC5142, IC5143, IC5144, IC5141, IC5138, IC5139, IC5135, IC5136, IC5137, IC5133, IC5134, IC5132, IC4960, IC5127, IC5115, IC5126, IC5114, IC5101, IC5102, IC5103, IC5105, IC5104, IC5098, IC5106, IC5111, IC5100, IC5109, IC5110, IC5107, IC5108, IC5113, IC5112, IC5097, IC5099, IC5085, IC5096, IC5084, IC5080, IC5081, IC5078, IC5079, IC5076, IC5077, IC5044, IC5045, IC5040, IC5041, IC5039, IC4958, IC4959, IC4961, IC4957, IC4955, IC4953, IC4954, IC4952, IC4949, IC4950, IC4947, IC4948, IC4946. 6. Product Code: 0042-0010-US. GTIN: 00813502010985. Serial Numbers: IC7251, IC7037, IC7023, IC7021, IC6996, IC6998, IC6999, IC6975, IC6997, IC6974, IC6972, IC6963, IC6964, IC6959, IC6958, IC6957, IC5971, IC5970. 7. Product Code: 0042-0040-US. GTIN: 00813502011401. Serial Numbers: IC7186.

Quantity Affected: 3,322 units

Reason for Recall

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

Type: Voluntary: Firm initiated

Recall Initiated: 2019-02-19

Company