ICY-3, Japan, Final Packaged Kit (Applause) IC-3893Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00849111050043), received between Feb 14, 2019 and Jan 23, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) 2024, IVTM THERAPY FOR THE CARDIOPULMONARY ARREST (CPA) PATIENT BEGAN USING THE ICY CATHETER (LOT UNKNOWN). ON (B)(6) 2024 IN THE EVENING, IT WAS NOTICED THAT THE SALINE IN THE SALINE BAG HAD DECREASED BY ABOUT 100 ML DURING THE REWARMING PHASE OF IVTM THERAPY. THE DWELL TIME WAS ABOUT 1 DAY. IT IS UNKNOWN IF THE CATHETER WAS REPLACED TO CONTINUE THERAPY. NO IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223984 ↗
• MalfunctionOct 2, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AT APPROXIMATELY 11:00 PM ON (B)(6) 2024, IVTM THERAPY BEGAN USING AN ICY CATHETER (LOT 201537) FOR THE CARDIOPULMONARY ARREST PATIENT. AT APPROXIMATELY 1:00 AM ON (B)(6) 2024, AN ALARM SOUNDED ON THE THERMOGARD XP IVTM SYSTEM INDICATING A SALINE LEAK. THE AMOUNT OF SALINE IN THE SALINE BAG HAD DECREASED, SO A SYRINGE WAS CONNECTED TO THE IN LUER AND BLOOD WAS CONFIRMED WHEN IT WAS DRAWN IN. SINCE THERE WAS NO SPARE THERMOGARD CATHETER, TEMPERATURE MANAGEMENT WAS CONTINUED WITH ARCTIC SUN. THE ALARM ON THE CONSOLE WAS CLEARED. NO DEVICE MALFUNCTION REPORTED FOR THE START-UP KIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355838 ↗
• InjuryMay 16, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A PATIENT USING AN ICY CATHETER (LOT #195762). AN EXPERIENCED PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT'S RIGHT FEMORAL VEIN, AND THE INSERTION WAS SMOOTH WITH NO ISSUES. AFTER 2 HOURS, THE CUSTOMER NOTED MINIMAL BLEEDING FROM THE CATHETER INSERTION SITE. WHILE ATTEMPTING TO STOP THE BLEEDING FROM THE INSERTION SITE, THE CUSTOMER NOTICED A DECREASING VOLUME OF SALINE FROM THE SALINE BAG. THE CUSTOMER SUSPECTED A CATHETER LEAK AND INFUSION OF ABOUT 10 CC OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE CUSTOMER REPLACED THE CATHETER TO CONTINUE THE IVTM THERAPY, AND THE CUSTOMER DID A PURSE-STRING SUTURE TO STOP THE BLEEDING. THE PATIENT'S BLOOD COAGULATION STATUS WAS PT-INR 1.34, APTT 180 SECONDS OR MORE. ALSO, THE CUSTOMER NOTICED THE SALINE LEAK BEFORE THE THERMOGARD XP IVTM SYSTEM GENERATED AN ALARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19337223 ↗
• MalfunctionFeb 7, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON 12/20/2023, IVTM THERAPY BEGAN FOR THE PATIENT. IMMEDIATELY AFTER STARTING THERAPY, THE SALINE BEGAN LEAKING FROM THE LUER OF THE START-UP KIT (SUK) (LOT 191352). THE CUSTOMER DID NOT TIGHTEN THE LUER TOO MUCH BUT FELT IT DID NOT MESH WELL. THE SUK WAS REPLACED WITH A NEW ONE, BUT THE LUER LEAK ISSUE WAS NOT RESOLVED. UPON FOLLOW UP, THE LEAKING LUER WAS DUE TO THE ICY CATHETER (LOT 188004). SUBSEQUENTLY, THE CATHETER WAS REPLACED WITH A NEW ONE TO CONTINUE THERAPY. THE SAME CONSOLE WAS USED TO CONTINUE THERAPY USING THE SECOND SUK AND CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661026 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN IVTM THERAPY WAS INITIATED FOR A RESUSCITATED POST-CARDIAC ARREST PATIENT (COVID-19 POSITIVE), AN ICY CATHETER (LOT #147266) WAS INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN AND APPROXIMATELY AFTER 13 HOURS OF THE IVTM THERAPY, THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM. THERE WAS NO LEAK FROM THE START-UP KIT (SUK), AND THE CUSTOMER SUSPECTED AN ICY CATHETER BALLOON LEAK. THE CUSTOMER TURNED OFF THE THERMOGARD SYSTEM AND REMOVED THE CATHETER. THE CLINICAL ENGINEER CONFIRMED A BALLOON LEAK BY INJECTING AIR INTO THE ICY CATHETER WHICH WAS SUBMERGED IN WATER. TREATMENT CONTINUED WITH ALTERNATE TEMPERATURE MANAGEMENT DEVICE. THERE WAS NO PROBLEM WITH THE THERMOGARD CONSOLE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14314077 ↗
• MalfunctionJun 11, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN ICY CATHETER WAS INSERTED INTO THE PATIENT AND APPROXIMATELY AFTER 2 HOURS OF IVTM THERAPY, THE USER OBSERVED DECREASING SALINE VOLUME IN THE SALINE BAG (ABOUT 200 ML). NO LEAK WAS NOTED ON THE START-UP KIT (SUK), SUSPECTING CATHETER LEAK. FOLLOWING THIS, THE PHYSICIAN DISCONTINUED IVTM THERAPY AND REMOVED THE CATHETER. ADJUNCT THERAPY WAS PERFORMED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687257 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD POST-CARDIAC ARREST SYNDROME (PCAS) FEMALE PATIENT WAS ADMITTED FOR THREE DAYS OF IVTM THERAPY FROM (B)(6) 2018. ZOLL ICY CATHETER (LOT #78167) WAS PLACED INTO THE PATIENT'S LEFT FEMORAL VEIN WITHOUT ISSUE. ON (B)(6) 2018, DVT (DEEP-VEIN THROMBOSIS) WAS DETECTED IN INFERIOR VENA CAVA AND LEFT COMMON ILIAC VEIN ON A CONTRAST ENHANCED CT (CECT). THE PHYSICIAN ADMINISTERED ANTICOAGULANT (HEPARIN, WARFARIN) TO THE PATIENT FOR DVT TREATMENT. AS OF (B)(6) 2018, THE PHYSICIAN STATED THE PATIENT'S OUTCOME IMPROVED. THE PATIENT HAD ALCOHOL LIVER DISEASE (ALD). THE CAUSE OF CARDIAC ARREST WAS HYPOKALEMIA (BLOOD'S POTASSIUM LEVELS WERE TOO LOW). NOTE THAT WHILE PATIENT BEING TRANSPORTED TO THE HOSPITAL, MANUAL CPR WAS PERFORMED AND CAUSED A LIVER DAMAGE. PER PHYSICIAN, IT WAS POSSIBLE THAT INFERIOR VENA CAVA WAS COMPRESSED BY THE HEMATOMA ON THE LIVER AND IT DECREASED BLOOD FLOW AND PROMOTED CLOT FORMATION. THE ICY CATHETER WAS DISPOSED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Thrombosis

  MAUDE report 8341815 ↗