Recall Z-3150-2026— Abiomed, Inc.

Class I FDA medical device recall by Abiomed, Inc., initiated 2026-08-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;. Reason: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly..

Recalling firm

Abiomed, Inc.

Classification

Class I

Status

Ongoing

Initiated

2026-08-12

Firm location

Danvers, MA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.