LivaNova Heater-Cooler System 3T Recalled for NTM Contamination Risk
LivaNova is recalling Heater-Cooler System 3T units to reduce the risk of NTM contamination by providing validated cleaning and disinfection instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a risk-of-harm product (NTM contamination) where the source text does not explicitly state that injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
LivaNova USA Inc. is recalling the LivaNova Heater-Cooler System 3T, a medical device used to circulate water through heat exchangers to warm or cool patients during cardiopulmonary bypass procedures lasting six hours or less. The recall is being conducted to reduce the risk of Non-Tuberculous Mycobacteria (NTM) contamination.
The recall affects 2,713 systems in the United States, including Puerto Rico, as part of a worldwide total of 9,309 systems. The matter was triggered by the clearance of K191402, limiting the affected distribution to the United States. Specific serial number ranges for various voltage models (120V, 127V, 200V, 208V, 230V, and 240V) are identified in the agency's structured product information.
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to mitigate the risk. Users should refer to the revised operating instructions for the updated protocols.
The recalled product
- 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.
- Manufacturer
- LivaNova USA Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
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