Abiomed, Inc. recalls Impella RP. Product Code: 0046-0011.

Recall date

January 27, 2026

Source

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

Recall number

Z-1471-2026

FDA classification

Class I

Brand / firm

Abiomed, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Why it was recalled

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

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. Product Code: 0046-0011.