Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne CL-2295Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00849111075176), received between Oct 21, 2024 and Jul 1, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2026, DURING IVTM THERAPY USING THE COOL LINE CATHETER (LOT 214575), THERE WAS BACKFLOW OF BLOOD. THEREFORE, THE CUSTOMER DETERMINED THAT THE CATHETER BALLOON HAD DAMAGED, CAUSING A SALINE LEAK. THE CATHETER HAD BEEN SMOOTHLY INSERTED ON THE FIRST ATTEMPT. THE DWELL TIME OF THE CATHETER WAS 10-20 MINUTES. SINCE THERE WERE NO PRODUCTS IN STOCK AT THE HOSPITAL, THE TREATMENT WAS SWITCHED TO MEDICATION. NO DEVICE MALFUNCTION WAS REPORTED FOR THE SUK. NO BLOOD WAS OBSERVED IN THE TUBING OF THE SUK. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25685223 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A 50-YEAR-OLD FEMALE PATIENT UNDERWENT IVTM THERAPY ON (B)(6) 2026, USING THE THERMOGARD SYSTEM FOLLOWING CARDIAC ARREST. A COOL LINE CATHETER (LOT # UNKNOWN) WAS INSERTED FROM A FEMORAL VEIN AND PLACED IN THE INFERIOR VENA CAVA. NO ADDITIONAL ADJUNCT PROCEDURES WERE PERFORMED. PRE-EXISTING BLOOD COAGULOPATHY HAD BEEN ASSESSED BEFORE HOSPITALIZATION, AND THE RESULTS WERE AVAILABLE BEFORE INITIATION OF THERAPY. THE PATIENT DID NOT RECEIVE DVT PROPHYLAXIS BEFORE DETECTION OF THROMBOSIS AND WAS NOT SYSTEMICALLY ANTICOAGULATED AT THAT TIME. THE CATHETER PLACEMENT WAS NOT ASSOCIATED WITH ANY VESSEL INJURY. THE PATIENT WAS ALSO NOTED TO HAVE A SUBARACHNOID HEMORRHAGE. ON (B)(6) 2026, AN ULTRASOUND CONFIRMED THE PRESENCE OF A THROMBUS IN THE INFERIOR VENA CAVA, WHICH WAS SUBSEQUENTLY SHOWN ON CT IMAGING TO EXTEND INTO THE RIGHT COMMON ILIAC VEIN. ANTICOAGULANT THERAPY WITH HEPARIN WAS THEN INITIATED. ON (B)(6) 2026, THE CATHETER WAS REMOVED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO FURTHER INFORMATION REGARDING THE PATIENT'S CONDITION FOLLOWING TRANSFER WAS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24914592 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak; Material Integrity Problem

  ON 3/17/2026, SIX DAYS AFTER INITIATING IVTM THERAPY USING THE COOL LINE CATHETER (LOT 212939) FOR A PATIENT WITH A HEAD INJURY, DURING COOLING, THE AIR TRAP ALARM SOUNDED, AND THE SALINE IN THE SALINE BAG WAS EMPTY. TEMPERATURE MANAGEMENT WAS TERMINATED AT THAT POINT. THE ALARM ON THE CONSOLE WAS CLEARED, AND THE CONSOLE IS BACK IN SERVICE. NO INJURIES TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820635 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2025, IVTM THERAPY USING A COOL LINE CATHETER (LOT 204870) WAS INITIATED. AT AROUND 4:00 AM ON (B)(6) 2025, A NURSE REPORTED TO THE CLINICAL ENGINEER THAT THE THERMOGARD HQ CONSOLE GENERATED AN AIR TRAP ALARM. THERAPY WAS DISCONTINUED. THE ALARM ON THE CONSOLE WAS CLEARED AND THE CONSOLE IS FUNCTIONING AS INTENDED. THE DWELL TIME OF THE CATHETER WAS ABOUT 6 DAYS. ON (B)(6) 2025, AZM SALES REP. CONTACTED THE PHYSICIAN AND CONFIRMED THAT A COOL LINE CATHETER HAD BEEN USED AND THAT THE BALLOON WAS SUSPECTED TO HAVE BEEN DAMAGED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763911 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem; Fluid/Blood Leak; Difficult to Remove; Material Integrity Problem

  AT 11:00 A.M. ON (B)(6) 2025, IVTM THERAPY USING COOL LINE CATHETER (LOT 199403) BEGAN. THE CATHETER WAS INSERTED INTO THE LEFT INTERNAL JUGULAR VEIN. AT 9:00 A.M. ON 8/24/2025, THE AMOUNT OF SALINE IN THE SALINE BAG WAS DECREASING, AND DAMAGE TO THE CATHETER BALLOON WAS SUSPECTED, SO THE MEDICAL DOCTOR CONSIDERED REPLACING THE CATHETER. AT 5:00 P.M. ON THE SAME DAY, THE DOCTOR CONSIDERED SURGICAL REMOVAL OF THE CATHETER, AS HE CONSIDERED IT DIFFICULT TO REMOVE. HOWEVER, THE CATHETER WAS ABLE TO BE REMOVED WITHOUT ANY PROBLEM. ADDITIONAL SURGERY/ SURGICAL REMOVAL WAS NOT NEEDED. NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092461 ↗
• MalfunctionAug 28, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2025, IVTM THERAPY USING COOL LINE CATHETER (LOT 206444) FOR A HEAD TRAUMA PATIENT BEGAN. ON (B)(6) 2025, IT WAS REPORTED THAT THE SALINE IN THE SALINE BAG HAD EMPTIED. THIS WAS CONFIRMED BY THE MEDICAL DOCTOR. IN ADDITION, AS IT WAS TIME TO END TEMPERATURE MANAGEMENT, THE CATHETER WAS REMOVED, AND TEMPERATURE MANAGEMENT WAS TERMINATED. SALINE INFUSION OF ABOUT 200-300 ML INTO THE PATIENT WAS SUSPECTED. THE DWELL TIME OF THE CATHETER WAS ABOUT 5 DAYS. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22918760 ↗
• MalfunctionMar 12, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IVTM THERAPY USING THE COOL LINE CATHETER (LOT 196904) WAS STARTED. APPROXIMATELY TWO HOURS AFTER THE START, THE AIR TRAP ALARM ON THE THERMOGARD XP IVTM SYSTEM SOUNDED, AND BLOOD WAS OBSERVED FLOWING INTO THE SALINE BAG. SINCE THE PATIENT'S CONDITION WAS STABLE, THE USE OF THERMOGARD WAS DISCONTINUED. THE ALARM ON THE CONSOLE WAS CLEARED. NO DEVICE MALFUNCTION IS SUSPECTED FOR THE START-UP KIT (SUK). NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590099 ↗
• MalfunctionNov 16, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  FOUR DAYS AFTER THE IVTM THERAPY STARTED, THE CUSTOMER NOTICED THE SOLUTION IN THE SALINE BAG HAD DECREASED. THE PHYSICIAN REPLACED THE START-UP KIT (SUK) (LOT # 200924) AND THE 500-ML SALINE BAG TO CONTINUE THE THERAPY. THE CUSTOMER PERFORMED THE CATHETER AND THE SUK LEAK CHECK PER IFU BEFORE REPLACING THE SUK, AS MEDICAL STAFF SUSPECTED A LEAK FROM THE SUK. HOWEVER, THE SALINE LEVEL DECREASED AGAIN, PROMPTING THE PHYSICIAN TO REPLACE THE COOL LINE CATHETER (LOT # 199403) AND THE SECOND SUK (LOT # UNKNOWN) TO CONTINUE THE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20701224 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AS REPORTED, DURING THE IVTM TREATMENT FOR THE TRAUMA PATIENT, THE CUSTOMER NOTICED THE SOLUTION IN THE SALINE BAG HAD DECREASED. THE PHYSICIAN PERFORMED THE COOL LINE CATHETER (LOT # 195818) CHECK AND THE CATHETER LEAK WAS SUSPECTED. NO FURTHER DETAILS WERE PROVIDED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501260 ↗