# FDA device recall: ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-

> recall · VERIFIED · 2026-06-11

Firm: Abiomed, Inc. · Class I · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th

- Company: Abiomed, Inc.
- Sector: medical devices
- 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.