Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–11 of 11 recalls
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.
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications.…
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected