Class I

Medical Device Recall: Impella RP. Product Code: 0046-0011.

Abiomed, Inc. · January 27, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

179 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1471-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.