Abiomed Impella RP with SmartAssist recall — FDA Z-1469-2026
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Overview of recall records associated with Abiomed, Inc., including dates, categories and classifications where available.
Classification mix: Class I: 25.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
This page summarizes recall records in which the official source identifies Abiomed, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.