SeriousFDAOngoing
Can cause serious harm or death.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Check the device or its packaging for
All Lots within Expiry/GTIN:00885672009793, 00813502010664
- Why
- 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.
- Distributed
- Distribution in the US state of MA
- Company
- Oscor Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2678-2026 · retrieved 10 July 2026
Read the official notice