# FDA device recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

> recall · VERIFIED · 2026-05-18

Firm: Abiomed, Inc. · Class I · Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

- Company: Abiomed, Inc.
- Sector: medtech
- 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.