Z-1498-2020 Class II Terminated
FDA device recall Z-1498-2020 was initiated by LivaNova USA Inc. on February 24, 2020 and is designated Class II. Reason for recall: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. The recall status is terminated (terminated August 4, 2022). Affected quantity: Total Worldwide=9309 systems (2713 system in U.S.).
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 24, 2020
- Termination Date
- August 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total Worldwide=9309 systems (2713 system in U.S.)
Product Description
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.
Reason for Recall
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
Distribution Pattern
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
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