Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC) with the below product descriptions and corre…

Summary

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can… Status: Ongoing.

Entities

• Abiomed, Inc.