Abiomed, Inc. recalls Impella RP Flex with SmartAssist; Product Number: 1000323;

Recall date

December 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0830-2025

FDA classification

Class I

Brand / firm

Abiomed, Inc.

Sold / distributed

Domestic: Nationwide Distribution International: Canada

Why it was recalled

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Impella RP Flex with SmartAssist; Product Number: 1000323;