SeriousFDAOngoing
Can cause serious harm or death.
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Check the device or its packaging for
All Lots within Expiry/GTIN:00885672009755/00813502011609
- 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-2680-2026 · retrieved 10 July 2026
Read the official notice