Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–31 of 31 recalls
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.
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.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Device packaged in incorrect outer box carton.