Device recall

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

FDA recall source

Recall number

Z-0208-2027

Event id

99778

Status

Ongoing

FDA classification

Class I

Recalling firm

Abiomed, Inc.

Report date

Nov 4, 2026

Posted

Oct 28, 2026

Initiated

Sep 18, 2026

Center classification date

Oct 28, 2026

Product code

OZD

Device type

Temporary Non-Roller Type Left Heart Support Blood 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.

Root cause

Under Investigation by firm

Quantity

428 units

Code info

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.

Distribution

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

Voluntary or mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States