FDAHealthJune 10, 2026
Oscor Inc. — Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
⚠️ 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.
Is this relevant to me?
- Geography
- US, MA
- Source agency
- FDA
- Category
- Health
- Published
- June 10, 2026
Distribution in the US state of MA
What's affected?
- Product
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- Brand
- Oscor Inc.
- Lot code
- within
Additional details
All Lots within Expiry/GTIN:00885672009793, 00813502010664
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 355 units.
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