FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Impella Introducer Kit recalled for potential leaking sheaths
OTHERMA
Abiomed Impella Introducer Kit recalled for leaking risk
Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.
- If you have this product in your facility, stop using affected lots immediately.
- Contact your Abiomed representative or the manufacturer for guidance on returns or replacement.
Hazard
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.
Sold states
Distribution in the US state of MA
Affected count
355 units
Manufactured in
4875 Palm Harbor Blvd, Palm Harbor, FL, United States
Products
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2678-2026More Oscor Inc. recalls
- FDA-Device2026-07-22Abiomed Impella introducer sheaths recalled for potential leakage
- FDA-Device2026-07-22Abiomed Impella Introducer Kit recalled for potential leaking in sheaths
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