ICY® Intravascular Heat Exchange Catheter Kit (Heparin) IC-3893AERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111075107), received between Aug 29, 2017 and Jun 30, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS HOSPITALIZED AND UNDERWENT IVTM THERAPY. A ZOLL ICY CATHETER WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN AND THE TARGET TEMPERATURE WAS SET TO 36 °C. FOUR HOURS AFTER THE CATHETER PLACEMENT, THE CUSTOMER REPORTED THAT THE 500ML BAG OF SALINE HAD EMPTIED. THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED OR THE FLOOR. THE CATHETER LEAK AND 500 ML OF SALINE INFUSION WAS SUSPECTED. THE CATHETER WAS NOT REPLACED, HOWEVER, SPECIFICS OF THE ALTERNATIVE THERAPY WERE NOT DISCLOSED. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215891 ↗
• MalfunctionJun 14, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  AT AN UNSPECIFIED TIME DURING IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AN AIRTRAP ALARM AND A CHECK SALINE ALARM. THE USER OBSERVED THAT THE SALINE BAG WAS EMPTY. UPON FURTHER INSPECTION NO SIGN OF LEAK ON THE SUK, OR ON THE PATIENT BEDSIDE WAS REPORTED. CATHETER LEAK WAS SUSPECTED. FOLLOWING THIS, THE USER DISCONTINUED IVTM THERAPY AND REMOVED THE CATHETER. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION PROVIDED. MFR 3010617000-2018-00654 FOR THERMOGARD CONSOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602583 ↗
• MalfunctionAug 29, 2017Leak/Splash; Leak/Splash

  AS REPORTED, 24 HOURS AFTER THE ICY CATHETER (LOT NUMBER: 73032) WAS INSERTED INTO A PATIENT'S LEFT FEMORAL, BLOOD WAS OBSERVED IN THE LUMEN OF THE START-UP KIT. THE HEALTHCARE TEAM BELIEVES THERE ARE LEAKS IN THE BALLOONS, THUS CAUSING SALINE TO BE LOST IN THE SUK. SUBSEQUENTLY, AN AIR TRAP ALARM OCCURRED. THE CATHETER WAS ULTIMATELY REPLACED. FOLLOWING THE REPLACEMENT, THE PATIENT WAS ABLE TO CONTINUE AND COMPLETE THEIR TEMPERATURE MANAGEMENT THERAPY. PER REPORTER, THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6827141 ↗