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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849111075220), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 death.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• DeathNov 21, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AFTER LESS THAN 24 HOURS OF IVTM THERAPY, CUSTOMER REPORTED THAT THE 500ML BAG OF SALINE HAD EMPTIED. THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED, FLOOR OR THE CONSOLE. SECOND SALINE BAG WAS PLACED AND ALSO DRAINED. THE ICY CATHETER (LOT #93192) WAS REMOVED AND SHOWS COMPROMISED BALLOON. THERE WAS NO REPORT OF THE THERMOGARD IVTM SYSTEM HAD ALARMED. THE SALINE FLUID WAS CLEARLY INFUSED INTO THE PATIENT. PATIENT DEATH WAS REPORTED. HOWEVER, CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 9359195 ↗