Class 2 Device Recall 3T Heater Cooler System

• Date Initiated by Firm: August 03, 2023
• Date Posted: October 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0073-2024
• Recall Event ID: 92882
• 510(K)Number: K191402
• Product Classification: Controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: 3T Heater Cooler System, REF: 16-02-85
• 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
• Recalling Firm/ Manufacturer: LivaNova Deutschland GmbH; Lindberghstr. 25; Munich Germany
• For Additional Information Contact: Enrico Milani; 89-323010
• Manufacturer Reason for Recall: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
• FDA Determined Cause: Labeling Change Control
• Action: On August 3, 2023 and August 28, 2023, LivaNova issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. LivaNova asked consignees to take the following actions: With the help of Attachment 1 of this letter, identify the location of the 3T Heater- Cooler device(s) where there may be an incorrect QRG. 2. Dispose of only the Quick Reference Guide rev 22 (bound of laminated pages). A new copy of the quick reference guide will be delivered to your facility as soon as possible. 3. Check whether the maintenance schedule reported in OI section 6.2.1 was followed. A. In case YES: You do not need to take any further action and you can continue to use the 3T device according to the OI. B. In case NO, B.1. Replace the aerosol collection if needed (ref. OI section 5.7.2) B.2. Disinfect the water circuit (ref. OI section 6.4) B.3. Monitor the water quality (ref. OI section 6.5.2) B.4. Remove the system from service until you receive the results of the water quality monitoring. B.5. In the case of Acceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4) you can continue to use the 3T device according to the OI. B.6. In case of Unacceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4), keep the system out of service, and contact your hygiene officer and your authorized service technician. LivaNova can provide an optional Deep Cleaning service for the system free of charge. Please contact your service technician or sales representative to request this service. 4. Fill in and sign the Customer Response Form (Attachment 1), and return it by email to LivaNova.FSCA@livanova.com or by hand to your LivaNova contact person, to confirm that you have received this letter, you have read and understood its content, you have disposed the incorrect copy and you have received the corrected QRG laminated cards. 6. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be
• Quantity in Commerce: 37 systems
• Distribution: US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DWC and Original Applicant = LivaNova Deutschland GmbH