Thermogard XP, Lang set A, Rohs, Refurb NARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111075565), received between May 28, 2021 and May 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Heating” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  A THERMOGARD XP CONSOLE (S/N (B)(4)) AND A QUATTRO CATHETER (LOT # 155467) WERE USED TO PROVIDE IVTM TREATMENT TO A PATIENT WHO NEEDED POST CARDIAC ARREST CARE. THE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN WITH NO UNUSUAL RESISTANCE NOTED, AND A RADIAL ARTERIAL LINE WAS ALSO PLACED FOR MEDICAL PURPOSES. THE DWELL TIME OF THE CATHETER HAD BEEN APPROXIMATELY 26 HOURS WHEN THE HYPOTHERMIA PHASE ENDED, AND THE REWARMING PHASE STARTED. BEFORE THE INITIATION OF REWARMING, THE PATIENT'S BODY TEMPERATURE WAS MEASURED AT 36 °C. THE TARGET TEMPERATURE WAS SET TO 37°C, AND THE CONSOLE WAS SET TO A CONTROLLED REWARMING RATE OF 0.2°C/HOUR. ABOUT 15 HOURS INTO THE REWARMING PHASE OF THE TREATMENT, IT WAS NOTICED THAT THE PATIENT WAS NOT APPROPRIATELY WARMING, WHICH PROMPTED TROUBLESHOOTING OF THE THERMOGARD SYSTEM. THE PATIENT'S BODY TEMPERATURE WAS AT 36.7 °C WHEN THE ISSUE WAS NOTED. UPON FURTHER VISUAL INSPECTION, THE CUSTOMER NOTED THAT THE TUBING OF THE START-UP-KIT (SUK) (LOT # UNKNOWN) WAS BULGING IN THE AREA AROUND THE ROLLER PUMP, PREVENTING THE PUMP ROTOR FROM TURNING. THE NURSES REPLACED THE 500-ML SALINE BAG TO TROUBLESHOOT THE ISSUE; HOWEVER, THE SUK TUBING WAS STI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905507 ↗