Thermogard HQTM Console ThermogardHQ, Lang set ARecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00849111075800), received between Jan 27, 2023 and Sep 30, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (25 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Cooling

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951839 ↗
• MalfunctionJun 23, 2026No Display/Image; Noise, Audible; Unexpected Shutdown

  DURING THE REWARMING PHASE, THE THERMOGARD HQ CONSOLE (SN (B)(6) POWERED OFF UNEXPECTEDLY. AFTER TURNING THE POWER BACK ON, THE FAN CAN BE HEARD RUNNING, BUT THE SCREEN REMAINS COMPLETELY BLANK AND THE ROLLER PUMP IS NOT OPERATING, MAKING THE DEVICE UNUSABLE. AN ALARM SOUNDS WHENEVER ANY BUTTON IS PRESSED. THERAPY WAS CONTINUED USING ANOTHER CONSOLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602613 ↗
• MalfunctionJun 18, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE THERMOGARD HQ TEMPERATURE MANAGEMENT CONSOLE (SN: (B)(6) WAS PROVIDING INACCURATE PATIENT TEMPERATURE READINGS, DISPLAYING VALUES APPROXIMATELY 6 DEGREES BELOW THE ACTUAL TEMPERATURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 25554444 ↗
• MalfunctionMay 8, 2026Visual Prompts will not Clear

  DURING SHIFT CHECK, THE CUSTOMER REPORTED THAT THE THERMOGARD HQ IVTM CONSOLE (SN (B)(6)) DISPLAYED PUMP STOP ALERT ERROR MESSAGE INTERMITTENTLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130944 ↗
• MalfunctionApr 23, 2026Connection Problem

  DURING THE INCOMING INSPECTION OF THE THERMOGARD HQ CONSOLE (SN (B)(6) AT THE AZM WAREHOUSE, ZOLL TECH SERVICE PERSONNEL NOTICED THAT ONE (BLUE LINE) OF THE CABLES LABELLED P22 WAS PULLED INSIDE. ALSO, ONE (BROWN, 6) OF THE CABLES LABELLED P21 WAS PULLED INSIDE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968575 ↗
• MalfunctionApr 17, 2026Use of Device Problem

  DURING THE REWARMING PHASE OF THE IVTM THERAPY, SALINE LEAKED FROM THE START-UP KIT (SUK) (LOT #222135) LFL TUBING IN THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE (SN TGHQ20163). PER THE REPORTER, THE PRESSURE BUILT UP AND BURST THE TUBE. THE CUSTOMER REPLACED THE CONSOLE WITH THE SUK TO CONTINUE THE THERAPY. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918699 ↗
• MalfunctionMar 25, 2026Smoking; Unexpected Shutdown

  AFTER TWO HOURS OF RUNNING, THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6)) POWERED DOWN WITH NO ALARM. SMOKE WAS SEEN COMING OUT OF THE VENT SIDE OF THE SYSTEM. PER THE BIOMED, THERE WAS NO SAFETY ISSUE OR CONCERN FROM THE SMOKE. ANOTHER SYSTEM WAS USED TO CONTINUE TREATMENT. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24692484 ↗
• MalfunctionMar 5, 2026Visual Prompts will not Clear

  DURING THE IVTM THERAPY, THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6) GENERATED A COOLANT LOW ALERT WHEN THE COOLANT LEVEL WAS FULL. THE HOSPITAL BIOMED WAS UNSURE OF THE TIME THE ALARM OCCURRED. THE BIOMED DUPLICATED THE ISSUE IN THE SHOP. THERE WAS AN INTERMITTENT COOLANT-LOW ALARM, AND TWO GREEN LEDS ILLUMINATED ON THE SENSOR PCB. NO CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526682 ↗
• MalfunctionFeb 19, 2026Use of Device Problem

  THE CUSTOMER REPORTED THE START-UP KIT (SUK) (LOT UNKNOWN) WAS DAMAGED IN PUMP ROTOR OF THE THERMOGARD HQ CONSOLE (SN (B)(6)). THE SYSTEM WAS TAKEN OUT OF USE FOR INVESTIGATION AND RESOLUTION. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 24397080 ↗
• MalfunctionJan 14, 2026Visual Prompts will not Clear

  DURING SETUP OF THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6)), THE AIR TRAP WOULD NOT RECOGNIZE A FULL AIR TRAP. THE SYSTEM WAS IN STORAGE FOR 10 MONTHS BEFORE SETUP WAS ATTEMPTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074845 ↗
• MalfunctionJan 6, 2026Use of Device Problem

  THE CUSTOMER REPORTED DURING USE OF THE THERMOGARD HQ CONSOLE (SN (B)(6) THE TARGET TEMPERATURE WAS 37 BUT WHEN THE PATIENT'S TEMPERATURE HIT 36.7, THE CONSOLE CHANGED TO MAINTENANCE MODE. THE CUSTOMER STATED SHE THEN WENT TO STANDBY MODE AND CHANGED HER TARGET TEMPERATURE TO 37.3. THE PATIENT'S TEMPERATURE WENT TO 36.8 AND THE CONSOLE DIDN'T GO TO MAINTENANCE MODE. SUBSEQUENTLY, THE TARGET TEMPERATURE WAS CHANGED BACK TO 37 DEGREES AND THE CONSOLE INITIATED MAINTENANCE MODE AT 36.7 DEGREES, STATING THE TARGET TEMPERATURE WAS REACHED. SHE BELIEVES THE UNIT IS OFF BY 0.3 DEGREES. THE CONSOLE WAS USED TO CONTINUE THERAPY IN MAINTENANCE MODE FOR THE REST OF HER SHIFT. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984633 ↗
• MalfunctionDec 26, 2025Visual Prompts will not Clear; Unexpected Shutdown; Visual Prompts will not Clear; Unexpected Shutdown

  DURING IVTM THERAPY, THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6) DISPLAYED AN ERROR MESSAGE. THE CUSTOMER WAS UNABLE TO SPECIFY THE NATURE OF THE ERROR BUT MENTIONED THAT THE CONSOLE WAS ALARMING AND THEN SHUT OFF. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 23897953 ↗
• MalfunctionDec 17, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED ON DAY 5 OF USE ON A 58-YEAR-OLD MALE PATIENT, THE START-UP KIT (SUK) WAS FOUND TO BE LEAKING, CAUSING PONDING OF SALINE AROUND THE THERMOGARD HQ CONSOLE (SN (B)(6)). THE CONSOLE DISPLAYED "AIR TRAP" ON THE SCREEN. THE SUK WAS REPLACED, AND THERMOGARD HQ CONSOLE WAS REPLACED WITH A THERMOGARD XP CONSOLE TO CONTINUE THERAPY. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834898 ↗
• MalfunctionDec 2, 2025Unexpected Shutdown; Unexpected Shutdown

  AN IVTM THERAPY WAS INITIATED USING THE THERMOGARD HQ CONSOLE (B)(6). TWO DAYS AFTER STARTING THE TREATMENT, THE THERMOGARD HQ CONSOLE SHUTDOWN UNEXPECTEDLY. THE THERMOGARD HQ CONSOLE DIDN'T DISPLAY ANY ERROR MESSAGES BEFORE POWERING OFF. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700862 ↗
• MalfunctionNov 5, 2025Use of Device Problem; Use of Device Problem

  DURING IVTM THERAPY, THE START-UP KIT (LOT # 200280) LFL TUBING AROUND THE ROLLER PUMP RUPTURED, CAUSING SALINE TO SPURT FROM THE TUBING INTO THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE (SN (B)(6). BECAUSE THE ROLLER PUMP WAS FILLED WITH SALINE, THE CUSTOMER STOPPED USING THE THERMOGARD HQ CONSOLE AND SWITCHED TO A SYSTEM FROM ANOTHER MANUFACTURER TO CONTINUE TEMPERATURE MANAGEMENT. THE ROLLER PUMP KNOB ON THE CONSOLE WAS OF THE OLD TYPE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480674 ↗
• MalfunctionSep 11, 2025Insufficient Heating; Use of Device Problem; Insufficient Heating; Use of Device Problem

  AN IVTM THERAPY WAS STARTED ON (B)(6) 2025, AT 07:03 PM USING THE THERMOGARD HQ CONSOLE (SN (B)(6) TO REWARM A PATIENT. THE TARGET TEMPERATURE WAS SET TO 36 DEGREES CELSIUS AT A RATE OF 0.1 °C/HR. DURING THE COOLING PHASE, THE CUSTOMER NOTED THAT THE START-UP KIT (SUK) FLOW INDICATOR WAS NOT SPINNING, AND THE TEMPERATURE WAS NOT DISPLAYED ON THE MONITOR. ADDITIONALLY, THE CUSTOMER REPORTED THAT THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE STOPPED ROTATING AT SOME POINT, AND REWARMING THERAPY WASN'T AS INTENDED. THE CUSTOMER OBSERVED THAT THE PATIENT'S TEMPERATURE WAS RISING STEADILY AND REACHED 34.1 DEGREES CELSIUS UNTIL APPROXIMATELY 7:00 AM ON (B)(6) 2025. I THEN SUDDENLY DROPPED TO 33.7 DEGREES CELSIUS AND REMAINED BELOW 34.1 DEGREES CELSIUS, ONLY RISING AGAIN AT 11:00 AM. ON (B)(6) 2025, AT 7:07 PM, THE CONTROLLED RATE INCREASED TO 0.2/HR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031790 ↗
• MalfunctionAug 27, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT DURING SETUP FOR TREATMENT, WHEN POWERING UP THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6), THE SYSTEM SHOWED A "COOLANT LOW" ALARM DESPITE A FULL COLDWELL OF COOLANT LEVEL. THE CUSTOMER THEN TURNED OFF THE THERMOGARD HQ SYSTEM AND TURNED IT BACK ON. AFTER RESTARTING, THE HQ CONSOLE DISPLAYED AN UNKNOWN ERROR MESSAGE. ANOTHER SYSTEM WAS USED TO TREAT THE PATIENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909403 ↗
• MalfunctionAug 7, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  ON JULY 11, DURING PATIENT USE USING THE THERMOGARD HQ CONSOLE (SN (B)(6)) AND THE START-UP KIT (SUK), (LOT 200280), THE CONSOLE EMITTED AN AUDIBLE "AIR TRAP FAULT" ALARM. THE CUSTOMER STOPPED USING THE CONSOLE. THERAPY WAS CONTINUED USING A BLANKET. NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744828 ↗
• MalfunctionAug 4, 2025Insufficient Heating; Insufficient Heating

  THE CUSTOMER REPORTED THAT DURING IVTM (INTRAVASCULAR TEMPERATURE MANAGEMENT) THERAPY UTILIZING THE THERMOGARD HQ CONSOLE (SN (B)(6) IN CONJUNCTION WITH A QUATTRO CATHETER, THE PATIENT FAILED TO REACH THE TARGET TEMPERATURE. IN ADDITION, THE COOLING RATE WAS TOO LOW. ALTHOUGH AN AIR TRAP ALARM WAS TRIGGERED DURING THE MAINTENANCE PHASE, NO PRIOR ALARMS WERE RECORDED IN THE SYSTEM LOGS. A REVIEW OF THE EEG (ELECTROENCEPHALOGRAM) LOG REVEALED NO EVIDENCE OF SHIVERING-RELATED ARTIFACTS, AND NURSING STAFF OBSERVED NO CLINICAL SIGNS OF SHIVERING AT THE BEDSIDE. THE SAME PATIENT WAS SUBSEQUENTLY CONNECTED TO A DIFFERENT THERMOGARD CONSOLE IN THE EMERGENCY DEPARTMENT, WHERE TARGET TEMPERATURE WAS SUCCESSFULLY MAINTAINED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697706 ↗
• MalfunctionJun 3, 2025Insufficient Cooling; Use of Device Problem; Insufficient Cooling; Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING THE COOLING PHASE OF THERAPY, THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6)) WAS SET TO 33 DEGREES, AND THE (B)(6), 144CM, 52.2KG FEMALE PATIENT WAS AT 34.1 DEGREES, BUT THE DEVICE WOULDN'T COOL BEYOND 34.1 DEGREES. THE PATIENT TEMPERATURE AT THE START OF THERAPY WAS 33.9 C. THE ROLLER PUMP STOPPED. NO ERROR MESSAGES WERE DISPLAYED ON THE CONSOLE. THERAPY HAD BEEN STARTED AT APPROXIMATELY 21:00 ON (B)(6) AND THE CONSOLE STOPPED AROUND 12:00 ON (B)(6). THEY TRIED SWITCHING TEMPERATURE PROBES FROM T1 TO T2, UTILIZING ESOPHAGEAL AND BLADDER TEMP PROBES BUT THE ISSUE PERSISTED. THE CLINICIANS OBTAINED ANOTHER CONSOLE AND CONTINUED TREATMENT FOR THE PATIENT USING THE SECOND CONSOLE WITHOUT ANY ISSUES. THE SAME CATHETER WAS USED TO CONTINUE THERAPY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137691 ↗
• MalfunctionJun 3, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THE THERMOGARD HQ CONSOLE (SN (B)(6)) DISPLAYED TCMID:01 (PUMP FAILED) ERROR MESSAGE AFTER UNBOXING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134245 ↗
• MalfunctionMay 13, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SETUP FOR A THERAPY, THE THERMOGARD HQ TEMP MGT CONSOLE (SN (B)(6)) DISPLAYED A "COOLANT LOW" ERROR MESSAGE. ANOTHER CONSOLE WAS USED TO TREAT THE PATIENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014854 ↗
• MalfunctionMay 1, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING INDUCED HYPOTHERMIA ON A PATIENT, A COMPONENT INSIDE THE ROLLER PUMP OF THE THERMOGARD HQ CONSOLE (SN (B)(6) BROKE, CREATING A SHARP EDGE. THIS SHARP EDGE CUT THE ROLLER TUBING ON THE START-UP KIT (SUK), CAUSING SALINE TO LEAK ONTO THE FLOOR. AS A RESULT, AN AIR TRAP ALARM WAS TRIGGERED, AND THE COOLING PROCESS FOR THE PATIENT WAS STOPPED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 21946173 ↗
• MalfunctionMar 19, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE INVESTIGATION ON (B)(6) 2025, THE THERMOGARD HQ CONSOLE (SN (B)(6) DISPLAYED MID:16 (SOFTWARE) DURING FUNCTIONAL TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649085 ↗
• MalfunctionMar 10, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  AFTER THE NEW SETUP, THE THERMOGARD HQ CONSOLE ((B)(6)) DISPLAYED A "COOLANT LOW" ALERT DESPITE THE GLYCOL LEVEL BEING AT MAXIMUM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557234 ↗