Automated Impella Controller recall (Abiomed, Inc.)

Medical deviceClass IOngoing

Summary: Abiomed, Inc. is recalling Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.. Reason: Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

What is being recalled

Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.

Why

Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

How serious is it

Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.

Where it was sold

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries: Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

How to tell if yours is affected

Product Code: 0042-0000-US, 0042-0000-UK, 0042-0000-EU, 0042-0000-IN, 0042-0000-CA; UDI:00813502010022, 00813502011296, 00813502011289, 00813502011418, 00813502011272; Serial No. IC1014, IC1029, IC1038, IC1043, IC1042, IC1061, IC1075, IC1096, IC1122, IC1190, IC1202, IC1203, IC1224, IC1231, IC1238, IC1269, IC1289, IC1446, IC1612, IC1741, IC1771, IC1852, IC1853, IC1708, IC1964, IC2071, IC2069, IC2154, IC2227, IC2314, IC2315, IC2029, IC2321, IC2428, IC2429, IC2521, IC2561, IC2562, IC2575, IC2664, IC2665, IC2691, IC2692, IC2739, IC2782, IC2840, IC2841, IC2848, IC2891, IC2976, IC2977, IC3009, IC3010, IC3154, IC3155, IC3244, IC3246, IC3342, IC3398, IC3347, IC3351, IC3512, IC3609, IC3714, IC3715, IC3772, IC3773, IC3806, IC3822, IC3823, IC3919, IC3975, IC3976, IC4041, IC4042, IC4045, IC4060, IC4250, IC4259, IC4295, IC4339, IC4616, IC4640, IC4641, IC4708, IC4831, IC4832, IC4884, IC5120, IC5151, IC5201, IC5056, IC5549, IC5605, IC5661, IC5662, IC5598, IC5720, IC5721, IC5745, IC5749, IC5750, IC5828, IC5984, IC6042, IC6321, IC6322, IC6328, IC6329, IC6359, IC6360, IC6403, IC6596, IC6597, IC6622, IC6623, IC6632, IC6637, IC6673, IC6825, IC6846, IC6834, IC6835, IC1387, IC1869, IC1909, IC2277, IC2278, IC2871, IC2872, IC3293, IC3294, IC3295, IC3674, IC3675, IC3784, IC3785, IC4741, IC5219, IC5220, IC5553, IC5911, IC5912, IC5926, IC5927, IC6289, IC6286, IC6287, IC6540, IC6583, IC6584, IC6585, IC6845, IC6925, IC7057, IC7074, IC7073, IC7441, IC7442, IC7591, IC1285, IC1416, IC3719, IC3720, IC3776, IC1825, IC1876, IC2175, IC2857, IC2996, IC3296, IC3486, IC3488, IC3890, IC4055, IC4323, IC4681, IC4682, IC4892, IC4984, IC4987, IC4973, IC5048, IC5421, IC5442, IC5464, IC5494, IC5687, IC5611, IC5722, IC5818, IC6065, IC6536, IC6582, IC6588, IC6589, IC6688, IC6694, IC6706, IC6707, IC6728, IC6738, IC6739, IC6740, IC6877, IC7388, IC7389, IC7390, IC7647, IC7649, IC7651, IC7652, IC7776, IC7777, IC5833, IC7444, IC7445, IC7446, IC7447, IC1284, IC1545, IC2368, IC2989, IC4331, IC4438, IC4856, IC2099, IC2823, IC3668, IC4099, IC4218, IC4611, IC4932, IC5490, IC5493, IC7407, IC7675, IC7686, IC7691, IC7692, IC7721, IC7809, IC3575, IC3576, IC3837, IC4065, IC4066, IC4451, IC4452, IC6330, IC3131, IC3132, IC2234, IC2469, IC3331, IC3669, IC3777, IC3828, IC4150, IC1396, IC1397, IC1724, IC1725, IC3050, IC5755, IC5756, IC3301, IC3302, IC3312, IC4675, IC4676, IC1577, IC1594, IC2877, IC6708, IC6806, IC5184, IC5218, IC7443, IC7585, IC5995, IC5996, IC5997, IC5998, IC5999, IC6001, IC6252, IC6253, IC6254, IC6139, IC6476, IC6477, IC6478, IC6475, IC7079, IC7080, IC7408, IC7409, IC7410, IC7411, IC3174, IC3166, IC3167, IC3213, IC3223, IC3475, IC4441, IC4525, IC5215, IC5910, IC7087, IC1280, IC1283, IC1345, IC1411, IC1398, IC2240, IC2557, IC3017, IC3178, IC3179, IC3322, IC3319, IC3490, IC3660, IC3813, IC4232, IC4237, IC4240, IC4242, IC4469, IC4626, IC4737, IC1586, IC1677, IC2021, IC2206, IC2245, IC3016, IC3049, IC3494, IC4329, IC4358, IC4563, IC4723, IC5757, IC6079, IC6080, IC6431, IC6580, IC6581, IC7719, IC3704, IC3705, IC5055, IC1766, IC5435, IC2451, IC2452, IC2453, IC2459, IC2460, IC2461, IC2449, IC1001, IC1179, IC1346, IC1481, IC1595, IC1715, IC1769, IC1790, IC1791, IC1911, IC1913, IC1912, IC2033, IC2035, IC2687, IC3661, IC3662, IC3802, IC4944, IC5034, IC5821, IC5824, IC6082, IC6083, IC6633, IC6636, IC7695, IC7716, IC9413, IC9414, IC9416, IC2442, IC2444, IC2443, IC2476, IC2477, IC2478, IC2479, IC2471, IC3127, IC3128, IC3129, IC3130, IC3306, IC3307, IC3308, IC3309, IC3656, IC3658, IC3663, IC3664, IC3665, IC3666, IC3783, IC3812, IC3888, IC3887, IC4068, IC4069, IC4257, IC4507, IC7578, IC3699, IC3700.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Abiomed, Inc. · all medical device recalls · recalls from September 2026

Official FDA record