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Abiomed, Inc. recalls Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Recalled December 13, 2023 · FDA recall Z-0440-2024 · 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 0042-000-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 →