LivaNova USA Inc.: LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Recall number

Z-1498-2020

Recalling firm

LivaNova USA Inc.

Product

LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

Status

Terminated

Initiated

2020-02-24

Posted

not on file

Terminated

2022-08-04

Reason

The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

Root cause

Device Design

Action

On 02/24/2020, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers informing them that the firm is executing a voluntary correction for their Heater-Cooler Systems and providing customers with a recently cleared operating instructions that includes a validated instructions for cleaning and disinfecting the external surfaces, connectors, fittings, and water circuits. The firm is instructing customers to discard or destroy older versions of the operating instruction and advising that all Heater-Cooler Systems in use at their facility should be upgraded with the 3T Aerosol Collection Set (vacuum canister and internal seal) to further reduce the risk of potential aerosol emission form the 3T system. These corrections apply to all 3T Systems currently in distribution, which includes upgrading any loaners that were previously distributed or that are pending distribution. Actions to be Taken by the Customer/User Use the Validated Operating Instructions Provided with this Customer Letter " The FDA cleared Operating Instructions are found in Attachment 1 as well as at Product Resources on www.livanova.com. - Please read and follow the instructions carefully. - Section 2.1.5 Integrating the HC3T into your facility provides guidance on the use of the 3T System in your facility, highlighting critical tasks that users had the most difficulty with during human factors testing. - Section 6 Maintaining the heater-cooler provides guidance on the maintenance of the 3T System including the validated cleaning and disinfection instructions. - Section 7.1.4 General performance data describes performance testing results that emphasize the importance of following the cleaning and disinfection instructions and consistently using the 3T Aerosol Collection Set during surgeries. Specifically, these results describe how (1) the disinfection and water maintenance process maintains water quality and (2) the 3T Aerosol Collection Set design change reduces the

Quantity

Total Worldwide=9309 systems (2713 system in U.S.)

Distribution

U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none

Lot, serial or model codes

Device Listing: E572259  Product Code Product Description Affected Serial Number range 16-02-80 Heater-Cooler 3T, 230V 16S10027 16S16874 16-02-81 Heater-Cooler 3T, 240V 16S10743 16S11708 16-02-82 Heater-Cooler 3T, 208V 16S10772 16S16840 16-02-83 Heater-Cooler 3T, 127V 16S11455 16S16509 16-02-85 Heater-Cooler 3T, 120V 16S10958 16S16847 16-02-95 Heater-Cooler 3T, 200V 16S12004 16S16818

510(k) numbers

["K052601"]

PMA numbers

not on file

Product code

DWC

Firm FEI

1718850

Firm city

Arvada

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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