Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Recalled December 13, 2023 · FDA recall Z-0441-2024 · Abiomed

Hazard

Pump not detected as connected to controller due to software issue. · FDA Class II

Sold at

US: AZ, CA, FL, NY & VA.

Description

Pump not detected as connected to controller due to software issue.

Product

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

Manufacturer(s)

Abiomed, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →