Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US;

Summary

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: T… Status: Ongoing.

Entities

• Abiomed, Inc.