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Heater-Cooler System
LivaNova Deutschland GmbH · Model 3T 208V ~ / 60Hz · UDI-DI 04033817900511
DWC
Prescription
10
510(k) clearances
9,165
Adverse events (204 deaths)
52
Recalls
10
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-24 | CardioQuip, LLC | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| 2023-10-24 | CardioQuip, LLC | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| 2023-10-19 | CardioQuip, LLC | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| 2023-10-19 | CardioQuip, LLC | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| 2023-08-03 | LivaNova Deutschland GmbH | The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device. |
| 2021-07-14 | Maquet Medical Systems USA | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species |
| 2021-06-24 | CardioQuip, LLC | There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potenti |
| 2021-06-17 | Gentherm Medical, LLC | There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM |
| 2021-05-12 | CardioQuip, LLC | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
| 2021-05-12 | CardioQuip, LLC | Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.