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Oscor Inc. recalls Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F
Recalled July 22, 2026 · FDA recall Z-2678-2026 · Oscor
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. · FDA Class I
Units
355 units
Sold at
Distribution in the US state of MA
Description
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.
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.
Manufacturer(s)
Oscor Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →