Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Recalled July 24, 2024 · FDA recall Z-2319-2024 · Abiomed

Hazard

Nine (9) Impella CP pumps failed inspection and were inadvertently released. · FDA Class I

Units

9 units

Sold at

Domestic only: FL, MA, OH TX.

Description

Nine (9) Impella CP pumps failed inspection and were inadvertently released.

Product

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Manufacturer(s)

Abiomed, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →