Reference notice · device
Abiomed, Inc. — Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella
The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Danvers, MA, US · Updated 9/16/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference