ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin), Non Lidocaine IC-3893Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849111075091), received between Nov 11, 2019 and May 28, 2021 — classified as 2 malfunctions.

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

• MalfunctionMay 28, 2021Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem; Fluid/Blood Leak; Use of Device Problem; Material Integrity Problem

  DURING IVTM THERAPY, THE ICY CATHETER WAS INSERTED INTO THE PATIENT RIGHT FEMORAL AND INSERTION WAS NOT SMOOTH, THE PHYSICIAN FELT RESISTANCE WHILE INSERTING THE CATHETER. THE PHYSICIAN IS AN EXPERIENCED WITH INTRAVASCULAR CATHETER PLACEMENT. APPROXIMATELY AFTER 2.30 HOURS, A HOSPITAL NURSE OBSERVED THE 500ML NORMAL SALINE (NS) BAG WAS NEARLY EMPTIED AND REPLACED IT WITH A NEW SALINE BAG. THE HOSPITAL NURSE DID NOT OBSERVED SALINE FLUID AROUND THE CONSOLE, BED OR ON THE FLOOR. PHYSICIAN SUSPECTED LEAKING ICY CATHETER (LOT #153887) ON THE BALLOON. THE THERMOGARD IVTM SYSTEM DID GENERATED AN "AIRTRAP" ALARM BUT WAS CLEARED BY THE USER AFTER REPLACING THE SALINE BAG AND THE CATHETER. THE SECOND CATHETER INSERTION ON THE PATIENT FEMORAL VEIN WAS SMOOTH. THERE WAS NO OTHER CENTRAL LINE PLACED ON THE SAME FEMORAL VEIN DURING TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905487 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE MAINTENANCE PHASE OF THE IVTM TREATMENT, THE THERMOGARD XP IVTM SYSTEM GENERATED "AIR TRAP" ALARM AND THE USER NOTICED EMPTY SALINE BAG. THE USER REPLACED THE SALINE BAG TO CONTINUE THE PATIENT TREATMENT. AFTER 2 HOURS, THE IVTM SYSTEM GENERATED "AIR TRAP" ALARM AND THE USER NOTICED EMPTY SALINE BAG AGAIN. THERE WERE NO TRACES OF SALINE ON THE FLOOR OR ON THE BED. THE USER FLUSHED THE IN PORT LUER WITH 5 ML OF SALINE AND OBSERVED BLOOD TINGE IN THE START-UP KIT (SUK) TUBING. SUSPECTING ICY CATHETER BALLOON LEAK. THE USER SWITCHED TO BLANKETS FOR TEMPERATURE MANAGEMENT AND CONTINUED TO USE THE CATHETER FOR MEDICATION ADMINISTRATION. PER USER, THE CATHETER INSERTION WAS DIFFICULT WITH BLOOD RETURNING INTO THE CATHETER. PER USER, THE CONSOLE MAINTAINED TARGET TEMPERATURE FOR THE WHOLE DURATION AND NO DEVICE MALFUNCTION WAS REPORTED ON THE IVTM CONSOLE. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306203 ↗