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

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

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

Source record id

Z-2360-2026

First seen by InfoSec Signals

Sep 23, 2026

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

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