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

Recall Z-2568-2025 — Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code:

U.S. FDA — Device Enforcement · United States · 2025-08-20 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2568-2025
Date of alert: 2025-08-20
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Abiomed, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 813502010022

Reported risk: Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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