The FDA has posted 11 enforcement recalls of temporary non-roller type left heart support blood pump devices since 2025, including 9 Class I (most serious) recalls. Most recent report: Sep 30, 2026.
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system perfo…
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
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.
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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;…
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.
Increased risk of purge leaks with Generation 1 purge cassettes.
Device packaged in incorrect outer box carton.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Temporary Non-Roller Type Left Heart Support Blood Pump”). Informational only — verify against the FDA before acting.