LivaNova Deutschland GmbH: Medical Device Recall in 2023 - (Recall #: Z-0073-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

3T Heater Cooler System, REF: 16-02-85

Product Classification:

Class II

Date Initiated: August 3, 2023

Date Posted: October 18, 2023

Recall Number: Z-0073-2024

Event ID: 92882

Reason for Recall:

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Status: Ongoing

Product Quantity: 37 systems

Code Information:

UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365

Distribution Pattern:

US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.

Voluntary or Mandated:

Voluntary: Firm initiated