# FDA device recall: Abiomed REF: 0052-3025, Introducer Kit for Impella   Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 

> recall · VERIFIED · 2026-06-10

Firm: Oscor Inc. · Class I · Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

- Company: Oscor 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.