LivaNova Deutschland GmbH: Medical Device Recall in 2024 - (Recall #: Z-0571-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software

Product Classification:

Class II

Date Initiated: October 18, 2024

Date Posted: December 4, 2024

Recall Number: Z-0571-2025

Event ID: 95665

Reason for Recall:

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

Status: Ongoing

Product Quantity: 38

Code Information:

UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288

Distribution Pattern:

US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.

Voluntary or Mandated:

Voluntary: Firm initiated