Altrix 8001Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 07613327277555), received between Feb 16, 2018 and Jul 14, 2025 — classified as 3 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (78 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 6, 2018Terminated

   Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter

   Z-0235-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE PATIENT TEMPERATURE IS CREEPING UP (WARMER) THAN PATIENT SET TEMPERATURE ON ALTRIX. THE TEMPERATURE GOAL IS 33.5, PATIENT WAS AT 33.5 AND NOW 34.3, FLOW IS OK, WATER TEMPERATURE IS 27-29, NO POSITION CHANGE, ESOPHAGEAL TEMPERATURE PROBE IN GOOD PLACE. THE PATIENT HAD BEEN AGITATED/MOVING MORE WHEN TEMPERATURE STARTED TO INCREASE. RN GOT MORE SEDATION FOR PATIENT AND CONFIRMED GIVING THE SEDATION TIME TO KICK IN AND SEEING IF THE TEMPERATURE GOES BACK TO GOAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500444 ↗
• MalfunctionMay 15, 2025Excessive Heating; Excessive Heating

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030555 ↗
• MalfunctionApr 23, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE UNIT IS NOT COOLING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889845 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKS ONTO PATIENT SUPPORT SURFACE AREA. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775973 ↗
• MalfunctionMar 26, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE DEVICE IS SHOWING AN ERROR POINTING TO THE MCB. AFTER CLEARING THE CODE THE DEVICE POWERED ON AND WAS ABLE TO RUN; BUT THE ALTRIX IS NOT COOLING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701443 ↗
• MalfunctionFeb 12, 2025Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE TEMPERATURE DEVIATION ALARM WAS OCCURRING. THE PATIENT WAS A BABY. THE DEVICE WAS IN AUTO MODE WITH A CURRENT PATIENT TEMPERATURE OF 32.4 AT THE BEGINNING OF CALL, THEN THE TEMPERATURE STARTED INCREASING CLOSER TO THE GOAL TO 32.6, WITH A TARGET TEMPERATURE OF 33.5. THE CURRENT WATER TEMPERATURE WAS 40 AND THE WRAPS FEEL WARM TO TOUCH. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21365678 ↗
• MalfunctionJan 30, 2025Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE PATIENT TEMPERATURE HAS BEEN STAYING BETWEEN 36.2-36.4. THE WATER TEMPERATURE IS 40 SET TO MAX/AUTO, TARGET TEMPERATURE IS 36.5, WITH AN ESOPHAGEAL PROBE AT 36.2 AND AX TEMPERATURE OF 36.4. THE PATIENT WAS NOT ADVERSELY CONSEQUENCE AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277570 ↗
• MalfunctionJan 10, 2025Insufficient Cooling; Insufficient Cooling

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129186 ↗
• MalfunctionDec 19, 2024Insufficient Cooling; Insufficient Heating; Insufficient Cooling; Insufficient Heating

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978105 ↗
• MalfunctionNov 22, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING WARMING THERAPY, THE BLANKET/PAD CONTACT SURFACE TEMPERATURE IS TOO WARM. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762117 ↗
• MalfunctionNov 20, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT THE DEVICE HAD A GOAL TEMPERATURE OF 33.5 BUT PATIENT TEMPERATURE WAS 30.7. IT WAS FURTHER REPORTED THAT THE BABY WAS OVERCOOLED BY 2.8 DEGREES AND THE BABY WAS SHIVERING.

  Patient problems: Chills

  MAUDE report 20734311 ↗
• MalfunctionNov 7, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE UNIT IS NOT COOLING. IT IS STUCK AT 37 DEGREES CELSIUS FOR OVER 1 HOUR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635254 ↗
• MalfunctionOct 8, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE PATIENT IS NOT MEETING THE TARGET GOAL TEMPERATURE. THE CURRENT PATIENT TEMPERATURE IS 101.5 WITH A GOAL TEMPERATURE OF 97.9, NO ALARMS ARE PRESENT. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401178 ↗
• MalfunctionSep 26, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THIS UNIT DOES NOT COOL WATER. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315982 ↗
• MalfunctionSep 25, 2024Excessive Heating; Excessive Heating

  IT WAS ALLEGED THAT A PATIENT WAS BURNED WHILE USING THE ALTRIX. SEVERITY AND TREATMENT INFORMATION HAVE NOT BEEN PROVIDED AT THE TIME OF REPORTING.

  Patient problems: Burn(s)

  MAUDE report 20302974 ↗
• MalfunctionSep 23, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE WATER TEMPERATURE IS COOLER THAN IT WAS PREVIOUSLY, PATIENT TEMPERATURE REMAINS 36.4. WITH A GOAL OF 36.5. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285172 ↗
• MalfunctionSep 23, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THE DEVICE WAS NOT WARMING AND THE PATIENT'S TEMPERATURE WAS NOTED TO BE 1.6 DEGREES BELOW THE SET TEMPERATURE (DURING THERAPY, BLANKET/WRAP CONTACT SURFACE TEMPERATURE NOT WARM ENOUGH). THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284053 ↗
• MalfunctionSep 16, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE RN CALLED ASKING ABOUT ALARMS ON ALTRIX SINCE THE PATIENT SET TEMPERATURE IS 99 AND THE PATIENT TEMPERATURE IS 101. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225122 ↗
• MalfunctionAug 22, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT AN RN CALLED FROM THE NICU ABOUT A PATIENT TEMPERATURE BEING LOWER THEN GOAL TEMPERATURE. IT WAS REPORTED THAT THEY WERE USING AUTO MODE WITH AN ESOPHAGEAL PROBE AND WERE UNABLE TO VERIFY WITH SECONDARY TEMPERATURE DUE TO THE TEMPERATURE BEING VERY LOW. THE GOAL TEMPERATURE WAS 33.5 WHICH WAS REACHED IN THE AM. THEN DURING NIGHT SHIFT THE TEMPERATURE STARTED DECREASING DOWN TO 31. THE CURRENT WATER TEMPERATURE IS BETWEEN 38 - 41.2. NO ALARMS WERE BEEPING AND THE HOSES AND WRAP FEEL WARM TO TOUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034461 ↗
• MalfunctionAug 7, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT THE PATIENT COOLED 2 DEGREES CELSIUS UNDER TARGET TEMPERATURE WITH NO PATIENT TEMPERATURE DEVIATION ALARMS FROM THE DEVICE. THE GOAL TEMPERATURE IS 33.5 DEGREES, PATIENT TEMPERATURE IS 31.6 DEGREES PER ESOPHAGEAL PROBE CONNECTED TO ALTRIX DEVICE. THERAPY STARTED AT 0445 AM, PATIENT STARTING TEMPERATURE WAS 36 DEGREES. CURRENT WATER TEMPERATURE IS 29.1 DEGREES. NOTED ON 90 MINUTE GRAPH WATER TEMPERATURE 25-29 DEGREES, AND FREQUENT DEVIATIONS OF PATIENT TEMPERATURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933116 ↗
• MalfunctionAug 7, 2024Excessive Cooling; Excessive Cooling

  IT WAS REPORTED THAT THE PATIENT COOLED 2 DEGREES CELSIUS UNDER TARGET TEMPERATURE WITH NO PATIENT TEMPERATURE DEVIATION ALARMS FROM THE DEVICE. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933002 ↗
• MalfunctionJul 31, 2024Insufficient Cooling; Insufficient Heating; Insufficient Cooling; Insufficient Heating

  IT WAS REPORTED THAT THE TEMPERATURE DEVIATION ALARM WAS OCCURRING. THE DEVICE WAS IN MANUAL MODE WITH A GOAL PATIENT TEMPERATURE OF 98.0 AND A CURRENT PATIENT TEMPERATURE OF 100. THE CURRENT WATER TEMPERATURE IS 80.8, WITH A WATER TEMPERATURE GOAL OF 55. THE PATIENT WAS NOT ADVERSELY AFFECTED AND NO CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877100 ↗
• MalfunctionJul 3, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE DEVICE WAS NOT COOLING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THE DEVICE IS CURRENTLY PENDING REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666438 ↗
• MalfunctionJun 7, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE PATIENT WASN'T MEETING THE GOAL TEMPERATURE (DURING THERAPY, BLANKET/WRAP CONTACT SURFACE TEMPERATURE NOT WARM ENOUGH). THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAY IN TREATMENT REPORTED. IT WAS CONFIRMED BY THE USER THAT THE UNIT WAS FUNCTIONING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490126 ↗
• MalfunctionJun 3, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT THE UNIT DOES NOT COOL VERY QUICKLY. NO PATIENT WAS AFFECTED, AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454690 ↗