Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) CL-2295AERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111075060), received between Mar 28, 2021 and Jul 14, 2023 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2023Insufficient Cooling; Insufficient Cooling

  DURING THE IVTM THERAPY FOR A LARGE PATIENT WEIGHING 17 STONE (238 LBS.) USING THE COOL LINE CATHETER (LOT #183057), THE CUSTOMER REPORTED THAT COOLING THE PATIENT TOOK LONGER THAN USUAL. THE PATIENT'S BODY TEMPERATURE AT THE INITIATION OF COOLING WAS ABOUT 39°C. THE RED PINWHEEL IN THE START-UP KIT (SUK) WAS NOT ROTATING, AND THE SALINE WOULDN'T CIRCULATE THROUGH THE TUBING. THERE WAS NO KINK NOTED ON THE CATHETER. THE CUSTOMER TRIED TWO DIFFERENT THERMOGARD XP IVTM SYSTEMS AND TWO DIFFERENT SUKS USING THE SAME CATHETER, AND THE ISSUE PERSISTED. THE SUK PINWHEEL DID NOT ROTATE BOTH TIMES, AND THE SALINE WOULDN'T CIRCULATE THROUGH THE TUBING. THE DOCTORS WAITED TO SEE IF THE PATIENT'S TEMPERATURE DROPPED WITHOUT NEEDING TO INSERT A NEW CATHETER & IT DID. THEREFORE, THE TREATMENT WAS STOPPED. THE CUSTOMER SAID THE ISSUE WAS POSSIBLY DUE TO USING A SMALL CATHETER. THE AMBIENT ROOM TEMPERATURE IS ALSO HIGHER THAN USUAL DUE TO THE WEATHER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329694 ↗
• InjuryJul 13, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING PATIENT TREATMENT, THE COOL LINE CATHETER (LOT # 151301) WAS PLACED IN THE JUGULAR VEIN WITHOUT ANY ISSUES. AFTER 2 HOURS OF THE TREATMENT, THE USER OBSERVED THE BLOOD COMING FROM THE CATHETER BOTH IN AND OUT LUERS INTO THE START-UP KIT'S TUBING, INDICATING THE CATHETER LEAK. THE THERMOGARD CONSOLE (SN (B)(4)) GENERATED AN AIR TRAP ALARM AND THE CONSOLE STOPPED. THE PATIENT TREATMENT WAS STOPPED AFTER REMOVING THE CATHETER, HOWEVER, THE SPECIFICS OF THE ALTERNATIVE THERAPY WERE NOT DISCLOSED. AFTER REMOVING THE CATHETER, THE CUSTOMER EXAMINED IT AND OBSERVED A DAMAGED BALLOON. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE CUSTOMER STATED THAT THE CATHETER GOT BROKEN IN THE PATIENT'S JUGULAR VEIN, THE PATIENT HASN'T DETERIORATED DUE TO THIS INCIDENT THOUGH AND A NEW CATHETER HAS BEEN INSERTED SUCCESSFULLY. HOWEVER, THE CUSTOMER DID NOT PROVIDE THE DETAILS ON THE EXACT TIME OF THE OBSERVED BROKEN CATHETER ISSUE AND HOW THE PATIENT TREATMENT WAS COMPLETED. AFTER THE TREATMENT, THE CONSOLE WAS TESTED WITH THE DEMO SUK AND WAS CONFIRMED AS FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO THE PATIENT. SEE MFR 3010617000-2021-00672 FOR THERMOGARD CONSOLE (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12156846 ↗
• InjuryMar 28, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A (B)(6)-YEAR-OLD MALE PATIENT (HEIGHT 5'9', WEIGHT (B)(6) LBS.) WAS HOSPITALIZED DUE TO PULSELESS ELECTRICAL ACTIVITY (PEA) /RESPIRATORY ARREST. THE POST-ARREST COOLING PROTOCOL WAS IMPLEMENTED DUE TO POOR NEUROLOGICAL RECOVERY. THE COOL LINE CATHETER (LOT# 152456) WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. THE PLACEMENT WAS DONE BY A RESIDENT PHYSICIAN WITH NO DIFFICULTIES DURING THE INSERTION. THE INITIAL PATIENT'S TEMPERATURE WAS AT 36.4°C WITH THE TARGET TEMPERATURE 34°C. AFTER 30 MINUTES OF CATHETER PLACEMENT, THE PATIENT GOT A SEIZURE AND THE PRESENCE OF THE BLOOD WAS OBSERVED IN THE COOLING PORTS OF THE CATHETER TO THE START-UP KIT (SUK) TUBING. THE CATHETER LEAK WAS SUSPECTED AND APPROXIMATELY 200 ML OF SALINE INFUSION. THE COOL LINE CATHETER WAS REPLACED TO CONTINUE THE PATIENT THERAPY WITHOUT FURTHER ISSUE. PER THE REPORTER, THE SEIZURE WAS NOT RELATED TO THE COOL LINE CATHETER PLACEMENT OR LEAK. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE PATIENT HAD AN ELEVATED INTERNATIONAL NORMALIZED RATIO (INR) BLOOD CLOTTING TIME OF 6.2 AT 07:50 AM (B)(6) 2021. THE PATIENT WAS AT A HIGH RISK OF BLEEDING DUE TO INCREASED INR. THE PATIENT HAD A MEDICAL HISTORY OF

  Patient problems: Convulsion/Seizure

  MAUDE report 11580226 ↗