Class 2 Device Recall LivaNova HeaterCooler System 3T

• Date Initiated by Firm: February 24, 2020
• Create Date: March 13, 2020
• Recall Status: Terminated on August 04, 2022
• Recall Number: Z-1498-2020
• Recall Event ID: 85098
• 510(K)Number: K052601
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: LivaNova USA Inc.; 14401 W 65th Way; Arvada CO 80004-3503
• For Additional Information Contact: 303-467-6306
• Manufacturer Reason for Recall: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWC