Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro: recall status

⚠ Recall found. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro is named in 2 official recalls in our current data. Details and the official notices are below — act on the remedy in the official notice.

Brand: Abiomed

Recalls naming this model

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2601-2026 · Official record ↗

FDA Class I · Medical device · July 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall — Abiomed, Inc.

Potential for thrombus formation during prolonged use of the introducer.

Official ID Z-2602-2026 · Official record ↗

See all Abiomed recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 1:09 AM UTC.