Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer CL-2295CORecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849111075510), received between Nov 1, 2017 and May 6, 2018 — 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.

• MalfunctionMay 6, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018 AT 1 PM, THE THERMOGARD IVTM SYSTEM WAS USED FOR PATIENT TREATMENT. AFTER 11 HOURS OF RUNNING THE THERMOGARD IVTM SYSTEM, IT WAS OBSERVED THAT THE SALINE FLUID LEVEL HAD DROPPED QUICKLY. THE DOCTOR REMOVED THE 1ST CATHETER AND FOUND IT HAD A LEAK. THE DOCTOR REPLACED THE 1ST CATHETER WITH A NEW CATHETER (2ND) AND THE SYSTEM FUNCTIONED PROPERLY. AROUND 1 AM, THE THERMOGARD IVTM SYSTEM ALARMED AND INDICATED THAT AN AIR TRAP LEAK WAS AT FAULT. THE DOCTOR AND BME TURNED OFF THE SYSTEM AND CLEANED UP ALL THE MOISTURE ON THE AIRTRAP. AFTER CLEANING, THE SYSTEM WAS RESTARTED AGAIN, BUT IT DID NOT FUNCTION. HOWEVER, THE USER STATED THAT THE SYSTEM FUNCTION PROPERLY AT A LATER UNSPECIFIED TIME. THE USER REPORTED THAT THE TWO CATHETERS HAD A LEAK. ONE CATHETER LEAKED IN ONE PLACE AND THE OTHER CATHETER LEAKED IN TWO PLACES. NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. REFERENCE MFR REPORTS: 3010617000-2018-00521 (2ND ICY CATHETER) AND 3010617000-2018-00522 (THERMOGARD XP CONSOLE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489574 ↗
• MalfunctionMay 6, 2018Leak/Splash; Leak/Splash

  ON (B)(6) 2018 AT 1 PM, THE THERMOGARD IVTM SYSTEM WAS USED FOR PATIENT TREATMENT. AFTER 11 HOURS OF RUNNING THE THERMOGARD IVTM SYSTEM, IT WAS OBSERVED THAT THE SALINE FLUID LEVEL HAD DROPPED QUICKLY. THE DOCTOR REMOVED THE 1ST CATHETER AND FOUND IT HAD A LEAK. THE DOCTOR REPLACED THE 1ST CATHETER WITH A NEW CATHETER (2ND) AND THE SYSTEM FUNCTIONED PROPERLY. AROUND 1 AM, THE THERMOGARD IVTM SYSTEM ALARMED AND INDICATED THAT AN AIR TRAP LEAK WAS AT FAULT. THE DOCTOR AND BME TURNED FUNCTION. HOWEVER, THE USER STATED THAT THE SYSTEM FUNCTION PROPERLY AT A LATER UNSPECIFIED TIME. THE USER REPORTED THAT THE TWO CATHETERS HAD A LEAK. ONE CATHETER LEAKED IN ONE PLACE AND THE OTHER CATHETER LEAKED IN TWO PLACES. NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. REFERENCE MFR REPORTS: 3010617000-2018-00520 (1ST ICY CATHETER) AND 3010617000-2018-00522 (THERMOGARD XP CONSOLE).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489573 ↗
• MalfunctionNov 1, 2017Device Issue; Device Issue

  AS REPORTED, PRIOR TO INSERTION THE ATTENDING PHYSICIAN OBSERVED THE BALLOONS ON THE SOLEX CATHETER HAD SEPARATED FROM THE CATHETER. ACCORDING TO THE REPORTER, THE BALLOONS WERE NOT INFLATED PRIOR TO THE PLACEMENT. ANOTHER SOLEX CATHETER KIT WAS OBTAINED. THERE WAS NO SIGNIFICANT DELAY IN THE REPLACEMENT NOR WAS THERE ANY REPORT OF PATIENT CONSEQUENCE AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994039 ↗