ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin IC-3893AERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00849111075077), received between Jan 27, 2017 and Oct 27, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  ON (B)(6) AT 9:40AM THE IVTM THERAPY WAS STARTED WITH THE THERMOGARD XP IVTM SYSTEM. THE ICY CATHETER (LOT 184825) WAS INSERTED VIA LEFT FEMORAL. ON (B)(6) AT 9:50AM, WHICH WAS DURING THE MAINTENANCE PHASE, THE CCU CHIEF NURSE MR. LAI NOTICED THE SALINE COLOR IN THE SALINE BOTTLE AND START-UP KIT (SUK) (LOT 185648) TUBING TURNED TO LIGHT YELLOW(PINK). AFTER DOING THE LEAK CHECK, THE YELLOW(PINK) SALINE WAS SEEN IN THE SYRINGE, THE CHIEF NURSE SUSPECTED LEAKING ON THE BALLOON CATHETER. DURING THE TIME, THERE WAS NO ALARM ON THE CONSOLE. THE CUSTOMER REPORTED A DECREASE OF AROUND 20CC OF SALINE IN THE SALINE BAG AND SUSPECTED 20CC OF INFUSION INTO THE PATIENT'S BLOODSTREAM. A NEW SET OF ICY AND SUK WAS REPLACED AT 11AM ON THAT DAY, AND THEN IVTM THERAPY CONTINUED AS INTENDED UNTIL THE END OF THE PROCEDURE. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022197 ↗
• MalfunctionFeb 22, 2019Use of Device Problem; Use of Device Problem

  DURING A (B)(6) FEMALE'S IVTM THERAPY, CUSTOMER REPORTED THAT THE PATIENT DID COMPLETED A 24 HOURS OF COOLING WITH NO ISSUE BUT DURING A COUPLE OF HOURS INTO WARMING PHASE, THE HOSPITAL NURSE NOTICED SALINE BAG WAS LOW, ALMOST EMPTY. CUSTOMER STOPPED TREATMENT, REMOVED THE ICY CATHETER (LOT #82508) AND PATIENT WAS PLACED WITH SURFACE COOLING TO CONTINUE WITH TREATMENT. ACCORDING TO CUSTOMER, SALINE FLUID WAS NOT FOUND OUTSIDE OF THE CONSOLE, ON THE FLOOR OR PATIENT'S BED. CONSOLE DID NOT SET OFF ALARM AND AIR TRAP WAS STILL FULL OF FLUID. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363872 ↗
• MalfunctionApr 11, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  ON (B)(6) 2018, THE MANUFACTURER WAS MADE AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2016. PER INFORMATION, THE PATIENT WAS INSERTED AN ICY CATHETER IN THE FEMORAL VEIN WITH NO REPORTED ISSUE. AT AN UNSPECIFIED TIME DURING IVTM THERAPY, LEAK ON THE CATHETER WAS OBSERVED WHEN CONTRAST FLUID WAS INJECTED INTO ONE OF THE INFUSION LUMENS. UPON INSPECTION, THE MEDIAN LINE OF THE CATHETER WAS OBSERVED TO HAVE SPLIT IN HALF APPROXIMATELY 2 CM IN LENGTH. THE REPORTER WAS UNABLE TO SPECIFY THE AMOUNT OF PRESSURE DURING CONTRAST INFUSION. FOLLOWING THIS, THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS PLACED TO CONTINUE THERAPY WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7423650 ↗
• MalfunctionJul 27, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. AN ICY CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN ON (B)(6) 2017. ON THE EVENING OF (B)(6)2017 THE NURSE RAISED CONCERN THAT THEY HAVE REPLACED THE SALINE BAG THREE TIMES (3 X 1000 ML) THROUGHOUT THE DAY. THE CATHETER WAS REPLACED WITH A COOL LINE CATHETER AND THERAPY WAS RESUMED. UPON REMOVAL, THE CUSTOMER CONFIRMED LEAK IN THE ICY CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6747711 ↗
• MalfunctionMay 8, 2017Leak/Splash; Leak/Splash

  A MALE PATIENT WAS HOSPITALIZED POST CARDIAC ARREST. A ZOLL CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN ON (B)(6) 2017. DURING WARMING PHASE, ON (B)(6) 2017, THE SALINE BAG WAS FOUND TO BE EMPTY. THE CATHETER WAS REMOVED AND THE PATIENT WAS NOT ABLE TO COMPLETE THE IVTM TEMPERATURE MANAGEMENT THERAPY. NO KNOWN PATIENT CONSEQUENCES REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552484 ↗
• MalfunctionFeb 21, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A ZOLL ICY CATHETER WAS INSERTED. THE IN DWELL TIME OF THE CATHETER WAS 36 HOURS. DURING WARMING PHASE, THE SYSTEM ALARMED "LOW AIRTRAP FLUID ". THE SALINE BAG HAD RUN DRY. THE CATHETER WAS REMOVED AND NO BLOOD TINGE OBSERVED. SURFACE INTERVENTION WAS USED TO CONTINUE AND COMPLETE THE TREATMENT. NO KNOWN PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6348103 ↗
• MalfunctionFeb 16, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND UNDERWENT TREATMENT FOR HYPOTHERMIA. PATIENT'S TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 38 DEGREE CELSIUS. THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 35 DEGREE CELSIUS. NO OTHER ADJUNCTIVE TEMPERATURE MANAGEMENT PROCEDURE WERE PERFORMED ON THE PATIENT. THE ICY CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN ON (B)(6) 2017. CATHETER INSERTION WAS SMOOTH. FIVE DAYS AFTER INSERTION, THE ATTENDING HEALTH CARE PROFESSIONAL (HCP) NOTED THAT THE THERMOGARD IVTM CONSOLE DISPLAYED A LOW FLUID ALARM AND THE SALINE BAG HAD RUN DRY; HOWEVER, NO FLUID WAS OBSERVED ANYWHERE AROUND THE PATIENT. THE PATIENT'S TEMPERATURE WHEN THE ISSUE NOTED WAS 35.0 DEGREE CELSIUS. THE CATHETER WAS REMOVED; HOWEVER, WAS NOT REPLACED. THE PATIENT IS IN A STABLE CONDITION. THERE WERE NO REPORTS OF PATIENT IMPACT AS A RESULT OF THE REPORTED ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6337257 ↗
• MalfunctionJan 30, 2017Leak/Splash; Leak/Splash

  A PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A ZOLL ICY CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN BY EXPERIENCED INSERTING PRACTITIONER. CATHETER INSERTION WAS SMOOTH. THE CATHETER WAS ALSO USED AS AN ACCESS FOR THE CONTRAST MEDICATION IN CT SCAN. NO OTHER ADJUNCTIVE TEMPERATURE MANAGEMENT PROCEDURES WERE PERFORMED ON THE PATIENT. THE PATIENT'S TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 36.4 DEGREE CELSIUS. THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 33 DEGREE CELSIUS. THE DWELL TIME OF THE CATHETER WAS 24 HOURS AND THE PATIENT'S TEMPERATURE WAS 33.8 DEGREE CELSIUS WHEN THE HEALTH PROVIDER NOTED THAT THE BANDAGE WAS SOAKED. THE ICY CATHETER WAS LEAKING. NEW CATHETER WAS USED TO CONTINUE THE TREATMENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6287860 ↗
• MalfunctionJan 30, 2017Leak/Splash; Leak/Splash

  AN ICY CATHETER WAS PLACED IN A PATIENT FOR THE THERAPY OF HYPOTHERMIA. AT AN UNSPECIFIED TIME LATER, IT WAS NOTICED THAT THERE WAS A LEAK AND APPROXIMATELY 2 LITERS OF SALINE WAS EMPTIED INTO THE PATIENT. THERE WAS NO PATIENT INJURY OR DEATH REPORTED. THE CATHETER WAS DISCARDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, WERE UNSUCCESSFUL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6286951 ↗
• MalfunctionJan 27, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE ON (B)(6) 2016. A ZOLL ICY CATHETER WAS PLACED IN A PATIENT. THE IN DWELL TIME OF THE CATHETER WAS 18 HOURS. APPROXIMATELY AROUND (B)(6), THE NURSE NOTICED THAT THE SALINE BAG VOLUME HAD DIMINISHED SIGNIFICANTLY. THE NURSE CHOSE TO REPLACE THE CATHETER. UPON PREPARING AND INSPECTING THE NEW REPLACEMENT CATHETER FROM ITS PACKAGING THE ON-DUTY NURSE PRACTITIONER NOTICE WHAT APPEARED TO BE A LACERATION IN THE BALLOON OF THE NEW UNUSED CATHETER. THIRD NEW CATHETER WAS INSERTED TO CONTINUE THE TEMPERATURE THERAPY. THE CUSTOMER STATED THAT THE POSSIBLE LEAK OF THE ICY CATHETER DID NOT RESULT IN SERIOUS INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6284975 ↗