Arctic Sun® 5000 50000000LRecalls & reported problems

Summary

The FDA's MAUDE database contains 388 adverse event reports that list this exact device (DI 00801741080159), received between Apr 3, 2018 and May 20, 2026 — classified as 13 injuries, 375 malfunctions.

The most frequently reported specific device problem is “Defective Component” (114 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jun 27, 2024Open, Classified

   If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.

   Z-2457-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 388 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Inaccurate Flow Rate; Nonstandard Device

  IT WAS REPORTED THAT PER WO EVALUATION, DECON TECH INSTALL TEST MIXING PUMP TO COOL IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS ON 13MAY2026, ERRATIC FLOW METER READINGS ON BYPASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234661 ↗
• MalfunctionMay 11, 2026Circuit Failure; Nonstandard Device

  IT WAS REPORTED THAT THE WO EVALUATION, THE CONTROL PANEL BOOTED TO DISC READ ERROR, USED U.I. TO COMPLETE DECONTAMINATION IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 05MAY2026, IT WAS REPORTED THAT THE NEUTRAL SIDE OF THE POWER INLET MODULE TO THE AC MAIN VOLTAGE CIRCUIT CARD WAS FOUND TO BE BLACKENED. THE CHILLER HAS A SHORT IN THE ELECTRICAL WIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143323 ↗
• MalfunctionMay 11, 2026Overheating of Device

  IT WAS REPORTED THAT THE WO EVALUATION, THE CONTROL PANEL BOOTED TO DISC READ ERROR, USED U.I. TO COMPLETE DECONTAMINATION IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 05MAY2026, IT WAS REPORTED THAT THE NEUTRAL SIDE OF THE POWER INLET MODULE TO THE AC MAIN VOLTAGE CIRCUIT CARD WAS FOUND TO BE BLACKENED. THE CHILLER HAS A SHORT IN THE ELECTRICAL WIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142805 ↗
• MalfunctionApr 29, 2026Nonstandard Device; Calibration Problem

  IT WAS REPORTED THAT THE PER WO EVALUATION, DURING CALIBRATION AN ERROR 1 APPEARED, PREWARM BYPASS FLOW ERROR DUE TO A FAULTY CIRCULATION PUMP IN AN ARCTIC SUN DEVICE. PER SAMPLE EVALUATION RESULTS ON 21APR2026, ERROR 3 (PRE-WARM NOMINAL FLOW) APPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029697 ↗
• MalfunctionApr 22, 2026Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT PER WO EVALUATION, ARCTIC SUN DEVICE CONTROL PANEL BOOTED TO RED SCREEN DURING ASSESSMENT. POWER CYCLES 5 TIMES AND THE CONTROL PANEL BOOTED UP NORMALLY. DURING REPAIR DISCOVERED NO FLOW READING /WILL BE REPLACED FLOW METER TO CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958741 ↗
• MalfunctionApr 9, 2026Failure to Pump; Calibration Problem

  IT WAS REPORTED THAT THE PER WO EVALUATION, DURING CALIBRATION AN ERROR 1 APPEARED, PREWARM BYPASS FLOW ERROR DUE TO A FAULTY CIRCULATION PUMP IN AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836446 ↗
• MalfunctionApr 9, 2026Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT PER WO EVALUATION, DECON TECH INSTALL TEST MIXING PUMP TO COOL IN AN ARCTIC SUN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831631 ↗
• MalfunctionFeb 18, 2026Circuit Failure

  IT WAS REPORTED THAT THEY WERE GETTING AN ALARM ON ARCTIC SUN DEVICE S/N (B)(6) THAT READS INLET WATER TEMPERATURE SENSOR OUT OF RANGE - HIGH RESISTANCE. PATIENT TEMPERATURE (PT) WAS 95F, TARGETED TEMPERATURE (TT) WAS 97F, WATER TEMPERATURE (WT) WAS 23.9F, FLOW RATE (FR) WAS 0LPM. ASKED NURSE TO TRY TO RESUME THERAPY AFTER CYCLING THE POWER AND THE ALARM COMES BACK. CONFIRMED ALARM 75 FROM EVENT LOG. ADVISED TO SEND DEVICE TO BIOMED LABELED WITH ALARM 75. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 06FEB2026, SPOKE WITH NURSE WHO CONFIRMED THE PATIENT WAS PUT ON A NEW DEVICE AND THERAPY RESUMED WITHOUT ISSUE. THERE WAS NO CHANGE IN PADS. STATED THE ALARM FROM THE FIRST DEVICE WOULD STOP THERAPY SO THEY COULD NOT GET A FLOW RATE OR THERAPY TO RUN AT ALL. THEY DENIED ANY ISSUES WITH FLOW. THE DEVICE HAD BEEN RETRIEVED FROM THE HALL YESTERDAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383221 ↗
• MalfunctionDec 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT PER WO EVALUATION, ARCTIC SUN DEVICE WAS READING FULL WHEN IT WAS EMPTY, INSTALLED TEST IO CARD. THERE WAS NO SUCTION, INSTALLED TEST CIRCULATION PUMP TO FILL. PER SAMPLE EVALUATION RESULTS ON 26NOV2025, PLASTIC SHELL SHAVINGS AND FOAM FOUND WITHIN THE UNIT. LEVEL SENSOR CUP CRACKED. LEVEL SENSOR TUBING EXPANDED. FLOW METER SHOWED EVIDENCE OF STICKING. THE SERVICERS NOTED THAT THE SHELL PIECES WERE FOUND WITHIN THE UNIT WHILE THE FOAM WAS FOUND WITHIN THE TANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728740 ↗
• MalfunctionNov 18, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BIOMED DOING FUNCTIONAL CHECK ON ARCTIC SUN DEVICE LOANER JUST RECEIVED AND STATED THE INLET PRESSURE (IP) WAS NOT REACHING -7PSI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584800 ↗
• MalfunctionNov 13, 2025Restricted Flow rate; Failure to Pump; Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT PER WO EVALUATION, ARCTIC SUN DEVICE WAS READING FULL WHEN IT WAS EMPTY, INSTALLED TEST IO CARD. THERE WAS NO SUCTION, INSTALLED TEST CIRCULATION PUMP TO FILL. PER SAMPLE EVALUATION RESULTS ON 26NOV2025, PLASTIC SHELL SHAVINGS AND FOAM FOUND WITHIN THE UNIT. LEVEL SENSOR CUP CRACKED. LEVEL SENSOR TUBING EXPANDED. FLOW METER SHOWED EVIDENCE OF STICKING. THE SERVICERS NOTED THAT THE SHELL PIECES WERE FOUND WITHIN THE UNIT WHILE THE FOAM WAS FOUND WITHIN THE TANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541938 ↗
• MalfunctionNov 12, 2025Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT PER WO EVALUATION, THE ARCTIC SUN DEVICE WAS GETTING LOW SUCTION AND CHANGED MIXING PUMP. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 10NOV2025, IT WAS REPORTED THAT THE TANK SEALS WERE FOUND DETERIORATED. INSTALLED TEST MIXING PUMP TO COOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534940 ↗
• MalfunctionNov 11, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT PER WO, THERE WAS A CRACK IN THE BOTTOM LEFT SIDE OF THE BEZEL IN AN ARCTIC SUN DEVICE. THE PROCESSOR CIRCUIT CARD SCREW, LOOP STRAP AND WING NUT ARE MISSING. DURING PRE-CALIBRATION THE UNIT HAD LOW FLOW IN BYPASS, SO THE FLOW METER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525810 ↗
• MalfunctionNov 4, 2025Inaccurate Flow Rate; Failure to Pump; Inaccurate Flow Rate; Failure to Pump

  IT WAS REPORTED THAT THE PER WO EVALUATION, THE ARCTIC SUN DEVICE WAS GETTING LOW SUCTION AND CHANGED MIXING PUMP. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 10NOV2025, IT WAS REPORTED THAT THE TANK SEALS WERE FOUND DETERIORATED. INSTALLED TEST MIXING PUMP TO COOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468474 ↗
• MalfunctionOct 21, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PER WO EVALUATION, THE ARCTIC SUN DEVICE READING NO FLOW, FLOW WAS OBSERVED THROUGH SHUNTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349226 ↗
• MalfunctionOct 17, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE BIOMED STATED THAT THEY RECEIVED THE LOANER ARCTIC SUN DEVICE, AND IT WOULD NOT FILL, NO SUCTION AT LEFT PORT. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 31MAR2025, SAMPLE HAS BEEN RECEIVED FOR REPAIR. NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. PER ADDITIONAL INFORMATION UPDATED BASED ON EVALUATION ON 23JUN2025, FLOW METER BEING REPLACED POST REPAIR DUE TO LOW FLOW IN BYPASS MODE NOT MEETING MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327844 ↗
• MalfunctionJun 27, 2025Decreased Pump Speed; Decreased Pump Speed

  IT WAS REPORTED THAT THE BIOMED STATED THAT THEY RECEIVED THE LOANER ARCTIC SUN DEVICE, AND IT WOULD NOT FILL, NO SUCTION AT LEFT PORT. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 31MAR2025, SAMPLE HAS BEEN RECEIVED FOR REPAIR. NO PATIENT INVOLVED AT THE TIME OF THE MALFUNCTION. PER ADDITIONAL INFORMATION UPDATED BASED ON EVALUATION ON 23JUN2025, FLOW METER BEING REPLACED POST REPAIR DUE TO LOW FLOW IN BYPASS MODE NOT MEETING MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346211 ↗
• MalfunctionJun 12, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT WHILE OPERATING THE SN: (B)(6) ARCTIC SUN DEVICE, THE NICU NURSE ENCOUNTERED AN ERROR MESSAGE STATING. REQUESTED DATA NOT PLACED INTO MEMORY BECAUSE OF AN I/O ERROR. UPON ACKNOWLEDGING THE MESSAGE BY PRESSING ""OK,"" THE DEVICE SCREEN FROZE AND BECAME UNRESPONSIVE. THE MALFUNCTIONING DEVICE WAS PROMPTLY REPLACED WITH A FUNCTIONAL UNIT SOURCED FROM THE ADULT CARE DEPARTMENT TO ENSURE CONTINUITY OF PATIENT CARE. USER WAS GUIDED TO THE SETTINGS MENU AND ADJUSTED THE LOW WATER LEVEL (LWL) TO 10. THE HIGH-WATER LEVEL (HWL) WAS ALREADY SET TO 40°C, AS THE REPLACEMENT DEVICE WAS A STAT UNIT. REWARM TAB READS FROM 34.2°C TO 36.5°C AT A RATE OF 0.5°C PER HOUR. THE PATIENT¿S CURRENT TEMPERATURE WAS 33.8°C. THE USER REPORTED THAT THE RESERVOIR FELT COLD UPON RECEIVING THE DEVICE FROM THE ADULT UNIT BUT CONFIRMED THAT EVERYTHING APPEARS TO BE FUNCTIONING PROPERLY NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194232 ↗
• MalfunctionJun 12, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT WHILE OPERATING THE SN: (B)(6) ARCTIC SUN DEVICE, THE NICU NURSE ENCOUNTERED AN ERROR MESSAGE STATING. REQUESTED DATA NOT PLACED INTO MEMORY BECAUSE OF AN I/O ERROR. UPON ACKNOWLEDGING THE MESSAGE BY PRESSING ""OK,"" THE DEVICE SCREEN FROZE AND BECAME UNRESPONSIVE. THE MALFUNCTIONING DEVICE WAS PROMPTLY REPLACED WITH A FUNCTIONAL UNIT SOURCED FROM THE ADULT CARE DEPARTMENT TO ENSURE CONTINUITY OF PATIENT CARE. USER WAS GUIDED TO THE SETTINGS MENU AND ADJUSTED THE LOW WATER LEVEL (LWL) TO 10. THE HIGH-WATER LEVEL (HWL) WAS ALREADY SET TO 40°C, AS THE REPLACEMENT DEVICE WAS A STAT UNIT. REWARM TAB READS FROM 34.2°C TO 36.5°C AT A RATE OF 0.5°C PER HOUR. THE PATIENT¿S CURRENT TEMPERATURE WAS 33.8°C. THE USER REPORTED THAT THE RESERVOIR FELT COLD UPON RECEIVING THE DEVICE FROM THE ADULT UNIT BUT CONFIRMED THAT EVERYTHING APPEARS TO BE FUNCTIONING PROPERLY NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193804 ↗
• MalfunctionJun 11, 2025Failure to Pump; Device Sensing Problem; Failure to Pump; Device Sensing Problem

  IT WAS REPORTED THAT THE BIOMED CALLED AND STATED THAT THE NURSE HAD REPORTED A 113 ALERT IN AN ARCTIC SUN DEVICE AND THEY BROUGHT THE UNIT DOWN TO BIOMED AND TURNED IT ON AND IT WAS LEAKING FROM THE BOTTOM. PER ADDITIONAL INFORMATION UPDATE FROM TTM ON 06JUN2025, BIOMED HAD LOANER DEVICE LEAKING FROM THE BOTTOM. PER REVIEW OF WO, RECOMMENDED TO DRAIN THE UNIT AND REFILL, IT WAS POSSIBLE THE NURSE OVERFILLED THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187514 ↗
• MalfunctionApr 30, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE NURSE HAD ARCTIC SUN DEVICE ALERTING LOW FLOW, BUT PATIENT WAS AT TARGET. HAD STOP THERAPY, EMPTY PADS AND DISCONNECT. FLUID DELIVERY LINE (FDL) SECURE AND IN LOCK POSITION. RECONNECTED HOLDING NOWHERE NEAR CLEAR CONNECTORS AND VERIFIED AUDIBLE CLICKS WITH EACH CONNECTION. STRAIGHTENED ALL LINES. RESTARTED THERAPY. SYSTEM DIAGNOSTICS: SHOWED THAT THE WATER FLOW RATE (WFR) WAS 0 L/M, INLET PRESSURE (IP) WAS -3.3PSI, CIRCULATION PUMP COMMAND (CPC) WAS 100 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, HEATER WAS 0, SYSTEM HOURS WERE 10,832 AND PUMP HOURS WERE 9771. HAD RN REMOVE THE PADS AND PLACE DEVICE IN MANUAL CONTROL. CIRCULATION PUMP COMMAND (CPC) WAS 45 PERCENTAGE, MIXING PUMP COMMAND (MPC) WAS 0, FLOW RATE (FR) WAS 0 L/M, INLET PRESSURE (IP) WAS -7. EXPLAINED TO INQUIRER THIS SOUNDS LIKE A FLOW METER ISSUE. HAD STOP THERAPY AND DISABLE MANUAL CONTROL. WALKED THROUGH SWAPPING DEVICE AND SENDING DEVICE DOWN FOR BIOMED EVALUATION LABELLED LOW FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934188 ↗
• MalfunctionApr 29, 2025Insufficient Cooling; Failure to Pump; Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT PER WO EVALUATION THEY INSTALLED TEST MIXING PUMP TO COOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926437 ↗
• MalfunctionFeb 20, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PER PREVENTIVE MAINTENANCE, WHEN POWER ON THE ARCTIC SUN DEVICE AN UNEXPECTED CHIRPING SOUND WAS HEARD. DUE TO AN UNEXPECTED CHIRPING SOUND, PUMP HEAD WILL BE REPLACED. PER SAMPLE EVALUATION RESULTS ON 26DEC2024, CIRCULATION PUMP MOTOR FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423941 ↗
• MalfunctionJan 27, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT PER PREVENTIVE MAINTENANCE IN AN ARCTIC SUN DEVICE, THERE WAS INVERTED SCREEN FOR THE CONTROL PANEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240762 ↗
• MalfunctionJan 21, 2025Insufficient Cooling; Failure to Pump; Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE DID NOT COOL DURING DECON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199656 ↗