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Recall

Oscor Inc.: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart p Recall

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 details: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

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Agency
FDA
Record ID
Z-2678-2026
Canonical
https://claimwatch-mvp.vercel.app/item/oscor-inc-abiomed-ref-0052-3025-introducer-kit-for-impella-hemostatic-peel-away-introducer/

What happened?

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 details: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.

Who may be affected?

Distribution in the US state of MA

What should consumers do?

Affected quantity: 355 units

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