Recall Z-1498-2020 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
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.
| Date | Feb 24, 2020 |
| Status | Terminated |
| 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 Co |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH, Jun 6, 2006 |