Abiomed, Inc.: Temporary Non-Roller Type Left Heart Support Blood Pump

Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.

Tags

FDA recall, medical device, class 3, Unknown, Under Investigation by firm, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISA 3: Information Systems Acquisition, Development and Implementation; CISA 5: Protection of Information Assets

Source record id

Z-3251-2026

First seen by InfoSec Signals

10/9/2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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