Class IOngoingZ-2602-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Abiomed, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 20 recalls
Class IOngoingZ-2601-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2600-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2599-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2457-2026
Abiomed, Inc. recalls Impella CP Set with SmartAssist. Product Codes: 1000080
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Abiomed, Inc.MAJun 24, 2026
Class IOngoingZ-2360-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Abiomed, Inc.MAJun 24, 2026
Class IOngoingZ-2238-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and correspondin…
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2.…
Abiomed, Inc.MAJun 3, 2026
Class IOngoingZ-2211-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process;…
Abiomed, Inc.MAJun 3, 2026
Class IOngoingZ-1591-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
Abiomed, Inc.MAApr 8, 2026
Class IOngoingZ-1589-2026
Abiomed, Inc. recalls Purge Cassette
Increased risk of purge leaks with Generation 1 purge cassettes.
Abiomed, Inc.MAApr 8, 2026
Class IOngoingZ-1471-2026
Abiomed, Inc. recalls Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class IOngoingZ-1470-2026
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026