Z-1498-2020Class II

LivaNova Heater-Cooler System 3T -

Name: Z-1498-2020 LivaNova Heater-Cooler System 3T -
Creator: LivaNova USA Inc.
Published: 2020-02-24
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2020-02-24 / Terminated / root cause: design

FDA source

LivaNova USA Inc. began a recall of 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... on 2020-02-24. FDA classified it as Class II and gives the reason as "The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1498-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-24
Posted: 2020-03-13
Terminated: 2022-08-04
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.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1498-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1498-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

Product code DWC

K052601Class IIStockert Heater-Cooler System 3TSorin Group Deutschland GmbH / cleared 2006-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)