Abiomed, Inc.

Abiomed, Inc.: 12 recalls listed since January 2026 across FDA; 10 rated high risk.

By year

The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.

Moderate riskFDASep 21, 2026Software defect

The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.

High riskFDASep 16, 2026Device defect

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.

High riskFDAJul 10, 2026Manufacturing problem

Potential for thrombus formation during prolonged use of the introducer.

High riskFDAJun 25, 2026Device defect

Impella CP Set with SmartAssist can cause low purge pressure alarms and loss of circulatory support.

High riskFDAJun 18, 2026Device defect

The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.

High riskFDAJun 12, 2026Software defect

The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.

High riskFDAMay 28, 2026Device defect

The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.

High riskFDAMay 22, 2026Device defect

Purge Cassette has an increased risk of purge leaks.

High riskFDAMar 31, 2026Device defect

The Automated Impella Controller may delay its purge system blocked alarm when used with certain pumps.

High riskFDAMar 27, 2026Device defect

The Impella RP devices have a sensor that may malfunction, causing sensor values to drift.

High riskFDAFeb 27, 2026Device defect

The Impella 5.5 with SmartAssist S2 Set is packaged in an incorrect outer box carton.

Moderate riskFDAJan 8, 2026Device defect