# FDA device recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product 

> recall · VERIFIED · 2026-05-22

Firm: Abiomed, Inc. · Class I · Potential for thrombus formation during prolonged use of the introducer.

- Company: Abiomed, Inc.
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.