Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0441-2024 — Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

U.S. FDA — Device Enforcement · United States · 2023-10-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0441-2024
Date of alert
2023-10-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abiomed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00813502011401
Reported risk: Pump not detected as connected to controller due to software issue.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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