The FDA has posted 20 enforcement recalls from Abiomed, Inc. since 2025, including 19 Class I (most serious) recalls. Most recent report: Jul 1, 2026.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Potential for thrombus formation during prolonged use of the introducer.
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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.
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.…
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;…
Increased risk of purge leaks with Generation 1 purge cassettes.
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.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Firm name as filed with the FDA: “Abiomed, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.