CritiCool Thermoregulation Device Recalled Due to Pump Failure
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text reports one death potentially related to this device failure. Per the severity rubric, the presence of reported deaths triggers a Critical (5) classification regardless of other factors.
Plain-English summary
Belmont Instrument Corporation is recalling the CritiCool thermoregulation device used to deliver thermoregulation therapy. The recall affects 158 units distributed in the United States and 803 units distributed internationally.
The device may experience premature pump failure that triggers a HALT 4 error. Once this error occurs, the device cannot recover from it even after a reboot, preventing delivery of the prescribed thermoregulation therapy and potentially delaying critical treatment.
One death has been reported that may potentially be related to this device failure. Healthcare providers using the CritiCool device should verify whether they have affected units and contact Belmont Instrument Corporation for guidance.
The recalled product
- Product
- CritiCool, thermoregulation device
- Manufacturer
- Belmont Instrument Corporation
- Hazard
- pump-failure
- treatment-failure
- device-error
Distribution
Distributed nationwide across the United States.
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