Official recall notice

FDA DeviceClass INotable

FDA Recall: Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf

Recall date
2026-07-22
FDA class
Class I

Why it was recalled

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.

Product 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.

Affected products

All Lots within Expiry/GTIN:00885672009786/00813502010558

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