Automated Impella Controller With Impella Connect

Recall Summary The Automated Impella Controller (AIC) with certain software versions (6.0.1–6.0.3 and 7.1) can unexpectedly restart and stop working in patients who have had prolonged periods of minimal heart pulsing, particularly when sudden changes in heart pressure occur during high-level support. When this happens, the screen goes blank without warning, the pump stops providing support, and it takes up to 75 seconds to restart and resume operation. This recall affects devices distributed to hospitals, pharmacies, and laboratories in New Zealand.

Recalling firm

Bio-Excel (NZ) Limited trading as Bio-Excel (Australia) Pty Ltd

Product

Automated Impella controller with Impella Connect. [Device]. Model: Impella Controller, Impella Optical Controller, Optical, AIC, Impella Connect, Optical AIC w/Impella Connect, Optical, AIC, Impella Connect. Affected: Affected serial numbers - AIC with software version 6.0.1–6.0.3 and =7.1

Reason

The manufacturer has identified a software problem affecting the Automated Impella Controller (AIC) when used with a left, ventricular Impella device. The problem may occur in patients with prolonged minimal or absent pulsatility, defined as more than 80, minutes with an aortic placement signal below 12 mmHg., If a sudden change in left ventricular pressure occurs while left ventricular pressure calculation is active, typically at support, levels above P-3, the AIC may restart due to an internal error. Disabling the aortic placement signal and pressure display does, not prevent this.,...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-05-21

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/2b8566dc-bcac-4a99-b7b5-f58f01d7c743