Class 1 Device Recall Automated Impella Controller

• Date Initiated by Firm: September 18, 2026
• Date Posted: October 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0208-2027
• Recall Event ID: 99778
• PMA Number: P140003 P170011
• Product Classification: Temporary non-roller type left heart support blood pump - Product Code OZD
• Product: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
• Code Information: 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.
• FEI Number: 1220648
• Recalling Firm/ Manufacturer: Abiomed, Inc.; 22 Cherry Hill Dr; Danvers MA 01923-2575
• For Additional Information Contact: Morgaine Johnson; 978-646-1400
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Abiomed notified consignees on about 09/18/2026 via "URGENT MEDICAL DEVICE RECALL (REMOVAL)" letter. Consignees were informed of the issue and that affected units can continue to be used while awaiting service from Abiomed to ensure continuity of care. Consignees were instructed to identify if affected units are on hand, Abiomed will contact each consignee to coordinate the removal, update and return of affected devices, complete and return the provided business reply form by email to: Abiomed5510@sedgwick.com (or Fax to (866) 201-9339). If you have questions regarding returning this form, please contact (866) 482-2893. Inform all applicable personnel within your facility of the recall, and if any of the affected devices have been forwarded to another facility, to notify those facilities. If you have questions or concerns regarding this notice, please contact ra-abm-fieldaction@its.jnj.com or your local clinical field staff or call the Manager Product Issue Escalation & Field Actions at 978-646-1400.
• Quantity in Commerce: 428 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OZD