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

Product Code: 0042-0010-US, 0042-0010-UK, 0042-0010-EU, 0042-0010-IN; UDI: 00813502010985, 00813502010978, 00813502010961, 00813502011425; Serial No. IC6962, IC7004, IC7036, IC7170, IC7213, IC7214, IC7239, IC7241, IC7677, IC7787, IC7880, IC8105, IC8106, IC8295, IC8308, IC8315, IC8316, IC8335, IC8541, IC8543, IC11456, IC7937, IC9832, IC9833, IC5409, IC7798, IC7800, IC7946, IC8070, IC8337, IC8441, IC7825, IC8126, IC8630, IC8640, IC9804, IC11451, IC11497, IC8388, IC8751, IC9501, IC9989, IC10102, IC10103, IC10318, IC10589, IC10463, IC10979, IC11299, IC8164, IC9348, IC9500, IC9581, IC9648, IC9777, IC9793, IC9797, IC9915, IC9919, IC9922, IC10278, IC10302, IC10983, IC10984, IC10985, IC11174, IC11410, IC13231, IC13263, IC13264, IC13265, IC13681, IC13682, IC10040, IC10043, IC8401, IC8748, IC8980, IC8609, IC9178, IC9177, IC9324, IC9328, IC9557, IC9558, IC9744, IC9745, IC9746, IC9908, IC9921, IC9969, IC9970, IC10063, IC10064, IC10149, IC10150, IC10238, IC10239, IC10341, IC10366, IC10367, IC12407, IC12408, IC12409, IC13057, IC13060, IC13061, IC13064, IC8333, IC8494, IC12326, IC4952, IC5041, IC5158, IC5281, IC5283, IC5284, IC5403, IC5404, IC5413, IC5527, IC5588, IC5635, IC5636, IC5641, IC5643, IC5666, IC5667, IC5804, IC5805, IC5918, IC5921, IC6013, IC6343, IC6421, IC6422, IC6461, IC6463, IC6465, IC6777, IC6785, IC6944, IC6945, IC6946, IC7161, IC7233, IC7232, IC7235, IC7626, IC7738, IC7739, IC7792, IC7793, IC7826, IC7956, IC8012, IC8258, IC8423, IC8424, IC8499, IC8511, IC8723, IC8596, IC8665, IC8765, IC7827, IC7828, IC8404, IC11746, IC12344, IC12327, IC8426, IC13232, IC13698, IC7861, IC7862, IC8121, IC8222, IC8225.

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.

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.

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