Thermogard XP® Thermogard XP, Lang set A, Non-RohsRecalls & reported problems
Zoll Circulation, Inc. · The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zoll Thermogard XP temperature control console has 2,515 adverse event reports, including 3 deaths and 2 injuries. Most reports describe error or warning messages that will not clear, incorrect messages, sudden shutdowns, and failures to power on. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,522
- Deaths reported
- 3
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,522 adverse event reports that list this exact device (DI 00849111075022), received between Feb 18, 2016 and Sep 30, 2026 — classified as 3 deaths, 2 injuries, 2,517 malfunctions.
The most frequently reported specific device problem is “Visual Prompts will not Clear” (1,524 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Visual Prompts will not Clear1,524
- Device Displays Incorrect Message387
- Device Operates Differently Than Expected335
- Use of Device Problem262
- Device Issue102
- Failure to Power Up61
- Temperature Problem54
- Unexpected Shutdown51
Patient problems
- No Clinical Signs, Symptoms or Conditions822
- No Known Impact Or Consequence To Patient504
- Insufficient Information467
- No Consequences Or Impact To Patient374
- No Patient Involvement349
- No Information8
- Cardiac Arrest4
- Patient Problem/Medical Problem2
Recent adverse event reports
The 25 most recent of 2,522 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955203 ↗MalfunctionSep 25, 2026Visual Prompts will not Clear
Patient problems: Insufficient Information
MAUDE report 50892566 ↗MalfunctionSep 24, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892231 ↗MalfunctionSep 23, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874565 ↗MalfunctionSep 23, 2026Temperature Problem
The customer reported that the Thermogard XP IVTM System (SN TGXP10347) was in warming mode at 35 degrees but suddenly began cooling. No additional information was provided. It is unknown when the problem occurred. However, patient use information was requested, but no additional information was provided.
Patient problems: Insufficient Information
MAUDE report 50869701 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782467 ↗MalfunctionSep 15, 2026Visual Prompts will not Clear
Patient problems: Insufficient Information
MAUDE report 50781546 ↗MalfunctionSep 14, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764585 ↗MalfunctionSep 9, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700058 ↗MalfunctionAug 23, 2026Insufficient Heating
Patient problems: Insufficient Information
MAUDE report 50397603 ↗MalfunctionAug 13, 2026Visual Prompts will not Clear
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237814 ↗MalfunctionJul 27, 2026Visual Prompts will not Clear
Patient problems: Insufficient Information
MAUDE report 50009698 ↗MalfunctionJul 2, 2026Display or Visual Feedback Problem; Use of Device Problem
THE CUSTOMER REPORTED THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) IS SHOWING AN EXCESSIVE DEVIATION BETWEEN THE SET POINT AND ACTUAL TEMPERATURES. THE DEVICE IS ALSO REPORTED TO HAVE EXPERIENCED A PUMP FAILURE WITHOUT TRIGGERING AN ALARM. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25699456 ↗MalfunctionJun 26, 2026Visual Prompts will not Clear
THE CUSTOMER REPORTED THAT THE THERMOGARD CONSOLE (SN (B)(6)) DISPLAYED TCMID:05 (COOLANT DIFF FAILURE) ERROR. NO INFORMATION WAS SHARED WITH ZOLL ABOUT PATIENT TREATMENT STATUS OR IF THE SYSTEM WAS INTENDED FOR USE ON A PATIENT OR BEING TESTED.
Patient problems: Insufficient Information
MAUDE report 25644090 ↗MalfunctionJun 22, 2026Visual Prompts will not Clear
DURING IVTM THERAPY UTILIZING THE THERMOGARD CONSOLE (SN (B)(6), QUATTRO CATHETER (LOT #217027), AND THE START-UP KIT (SUK) (LOT #219591), AN AIR TRAP ALARM WAS TRIGGERED. A SALINE LEAK WAS SUSPECTED DUE TO A NOTICEABLE DECREASE IN SALINE VOLUME IN THE BAG. PER THE INSTRUCTIONS FOR USE (IFU), THE CATHETER WAS CHECKED FOR LEAKAGE. SUBSEQUENTLY, THE CONSOLE DISPLAYED A MID:13 (BG ADC) ERROR MESSAGE. IN RESPONSE, A NEW SUK WAS INSTALLED ON A DIFFERENT CONSOLE, AND THE CATHETER WAS REPLACED; THE TEMPERATURE MANAGEMENT THERAPY WAS RESUMED. NO PATIENT INJURY OR ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25574756 ↗MalfunctionJun 16, 2026Visual Prompts will not Clear
THE CUSTOMER REPORTED ON THE THERMOGARD XP IVTM SYSTEM (SN (B)(6), A MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGE OCCURS, AND EVEN THOUGH COOLANT IS PRESENT, THE CONSOLE INDICATES THAT THE COOLANT LEVEL IS LOW. THIS ISSUE OCCURRED BEFORE PATIENT USE. THE ERRORS WERE DISPLAYED IMMEDIATELY UPON POWERING ON THE CONSOLE. TREATMENT WAS STARTED USING A REPLACEMENT UNIT. NO IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25526341 ↗MalfunctionJun 11, 2026Visual Prompts will not Clear
THE CUSTOMER REPORTED THE THERMOGARD CONSOLE (SN (B)(6) DISPLAYED TCMID:05 (COOLANT DIFF FAILURE) ERROR. NO INFORMATION WAS SHARED WITH ZOLL ABOUT PATIENT TREATMENT STATUS OR IF THE SYSTEM WAS INTENDED FOR USE ON A PATIENT OR BEING TESTED.
Patient problems: Insufficient Information
MAUDE report 25480626 ↗MalfunctionJun 10, 2026Use of Device Problem
AS REPORTED, THE PRIME SWITCH ON THE THERMOGARD CONSOLE (SN (B)(6)) WAS FOUND TO BE NON-FUNCTIONAL, PREVENTING THE SUK FROM BEING PRIMED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25461682 ↗MalfunctionJun 9, 2026Visual Prompts will not Clear
THE CUSTOMER REPORTED THE THERMOGARD XP IVTM SYSTEM (SN (B)(6)) DISPLAYED A TCMID:06 (CE POST FAILURE) ERROR MESSAGE AFTER STARTING UP. THE CUSTOMER USED A SECOND THERMOGARD TO CONTINUE THE TREATMENT. NO IMPACT OR CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448215 ↗MalfunctionJun 4, 2026Use of Device Problem
THE CUSTOMER REPORTED LEAKAGE IN THE THERMOGARD XP IVTM SYSTEM ((B)(6) WITH NO FURTHER INFORMATION. THE CUSTOMER USED ANOTHER THERMOGARD CONSOLE TO CONTINUE TREATMENT. THE PATIENT WAS NOT IN DANGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402734 ↗MalfunctionJun 3, 2026Visual Prompts will not Clear
DURING THE REWARMING PHASE OF IVTM THERAPY, THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) DISPLAYED A MID:23 (PATIENT PROBE OFFSET) ERROR MESSAGE. NO TROUBLESHOOTING WAS PERFORMED. NO ALTERNATE CONSOLE OR COMPETITOR DEVICE WAS USED, AND THE TREATMENT WAS COMPLETED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382176 ↗MalfunctionMay 27, 2026Visual Prompts will not Clear
DURING PREVENTATIVE MAINTENANCE OF THE THERMOGARD XP IVTM SYSTEM (SN (B)(6), THE DEVICE FAILED THE FUNCTIONAL TEST AND DISPLAYED A COOLANT LOW MESSAGE EVEN THOUGH THE COOLANT IS FULL. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310941 ↗MalfunctionMay 27, 2026Visual Prompts will not Clear
THE CUSTOMER REPORTED THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) DISPLAYED TCMID:05 (COOLANT DIFF FAILURE) ERROR. NO INFORMATION WAS SHARED WITH ZOLL ABOUT PATIENT TREATMENT STATUS OR IF THE SYSTEM WAS INTENDED FOR USE ON A PATIENT OR BEING TESTED.
Patient problems: Insufficient Information
MAUDE report 25310741 ↗MalfunctionMay 27, 2026Visual Prompts will not Clear
BIOMED REPORTED THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) DISPLAYED TCMID:06 (CE POST FAILURE) ERROR MESSAGE. ANOTHER DEVICE WAS USED FOR THERAPY. THE PATIENT WAS NOT IN DANGER. NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310613 ↗MalfunctionMay 21, 2026Use of Device Problem
WHILE PREPARING AND INSPECTING THE THERMOGARD XP IVTM SYSTEM (SN TGXP12184) FOR USE, JUST PRIOR TO CONNECTING THE CONSOLE TO THE PATIENT, THE CUSTOMER NOTICED AN UNUSUAL NOISE COMING FROM THE CONSOLE'S ROLLER PUMP. AS A RESULT, THE CONSOLE WAS NOT USED, AND TREATMENT WAS INITIATED WITH ANOTHER CONSOLE. IT IS UNKNOWN WHETHER THE REPORTED ISSUE CAUSED ANY SIGNIFICANT DELAY IN TREATMENT DELIVERY. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.
Patient problems: Insufficient Information
MAUDE report 25247956 ↗
Other System, Hypothermia, Intravenous, Cooling devices
- ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin) IC-3893AEZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling5 deaths198 reports
- QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) IC-4593Zoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling13 deaths165 reports
- SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause Hep SL-2593Zoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling2 deaths154 reports
- ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) IC-3893Zoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling1 death154 reports
- SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EU SL-2593AEZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling2 deaths117 reports
- QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin E IC-4593AEZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling2 deaths98 reports
- QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) IC-4593Zoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling1 death87 reports
- ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) IC-3893Zoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling65 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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