System, Hypothermia, Intravenous, Cooling
FDA adverse event reports and recall history for system, hypothermia, intravenous, cooling (product code NCX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,355
- Deaths
- 44
- Injuries
- 261
- Malfunctions
- 4,041
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-01-27TerminatedNonconforming Material/Component
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
- 2007-02-15TerminatedOther
Alsius Cool Line Catheter, Model CL-2295A
Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
- 2007-02-15TerminatedOther
Alsius Cool Line Catheter, Model CL-2295AE
Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
- 2006-01-10TerminatedOther
Alsius CoolGard Temperature Regulation System
Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
- 2005-08-24TerminatedOther
Alsius CoolGard 3000 Temperature Regulation System
Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.
- 2004-11-25TerminatedOther
Alsius CoolGard 3000 patient temperature regulation system
Product alarms that there may be a power supply interruption.
- 2004-07-23TerminatedOther
Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Higher than expected rate of pump alarms occur under specific conditions.
- TerminatedLabeling design
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- TerminatedLabeling design
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- TerminatedLabeling design
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
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