Class I — UrgentReported 2026-03-11

Impella RP with SmartAssist. Product Code: 0046-0035.

Recalled by Abiomed, Inc.

Reason for Recall

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

Recall Number

Z-1469-2026

Classification

Class I

Status

Ongoing

Category

device

Initiated

2026-01-27

Reported

2026-03-11

Distribution

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

Code Info

Product Code: 0046-0035. UDI-DI: 00813502011869.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.