Abiomed, Inc.
Device Recalls (Class I)
Class I
Z-1469-2026
·
20260311
·
Ongoing
Product
Impella RP with SmartAssist. Product Code: 0046-0035.
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, ...
Source: openFDA Enforcement API