System, Hypothermia, Intravenous, Cooling
Cardiovascular · 21 CFR 870.5900
Recent MDR events
4,389 adverse event reports on file
- Thermogard XP®Jul 30, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00460
- Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit NeJul 30, 2026MalfunctionZoll Circulation, Inc3010617000-2026-00509
- Thermogard XP®Jul 29, 2026MalfunctionZoll Circulation, Inc3010617000-2026-00463
- Thermogard XP®Jul 29, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00465
- Thermogard XP®Jul 29, 2026MalfunctionZoll Circulation, Inc3010617000-2026-00462
- Thermogard XP®Jul 28, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00464
- ICY® Japan, Intravascular Heat Exchange Catheter Kit Japan Custom LuerJul 28, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00450
- Thermogard XP®Jul 27, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00447
- Thermogard XP®Jul 27, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00449
- Thermogard XP®Jul 27, 2026MalfunctionZoll Circulation, Inc.3010617000-2026-00442
Event type breakdown
Recalls
35 recall events for this product code
- Philips HealthcareTerminatedJan 27, 2014
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
Z-0845-2014 · View FDA record ↗ - Alsius CorporationTerminatedFeb 15, 2007
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.
Z-0502-2007 · View FDA record ↗ - Alsius CorporationTerminatedFeb 15, 2007
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.
Z-0503-2007 · View FDA record ↗ - Alsius CorporationTerminatedJan 10, 2006
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.
Z-0369-06 · View FDA record ↗ - Alsius CorporationTerminatedAug 24, 2005
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.
Z-1397-05 · View FDA record ↗ - Alsius CorporationTerminatedNov 25, 2004
Alsius CoolGard 3000 patient temperature regulation system
Product alarms that there may be a power supply interruption.
Z-0258-05 · View FDA record ↗ - Alsius CorporationTerminatedJul 23, 2004
Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Higher than expected rate of pump alarms occur under specific conditions.
Z-1159-04 · View FDA record ↗ - ZOLL Circulation, Inc.TerminatedUnknown
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion On
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0039-2022 · View FDA record ↗ - ZOLL Circulation, Inc.TerminatedUnknown
Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0040-2022 · View FDA record ↗ - ZOLL Circulation, Inc.TerminatedUnknown
ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)0084911107519
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Z-0041-2022 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
510(k) clearances
26 clearances for this product code
- Zoll Circulation, Inc.Jan 13, 2023
K223746 · Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- Zoll Circulation, Inc.Jun 2, 2022
K220008 · Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
- Zoll Circulation, Inc.Dec 20, 2021
K213031 · Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
- Seiratherm GmbHSep 15, 2016
K152946 · TEMPEDY
- Novocor Medical Systems, Inc.May 24, 2016
K153162 · Hypocore
- Zoll Circulation, Inc.Mar 24, 2016
K153226 · Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
- Zoll Circulation, Inc.Oct 30, 2015
K150046 · Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
- Zoll CirculationOct 3, 2014
K141139 · SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER