FDA recall Z-1470-2026

Product

Impella RP Flex with SmartAssist. Product Code: 1000323.

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-01-27

Report date

2026-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2026