Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit Custom CL-2295AERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00849111075213), received between Nov 20, 2017 and Jun 9, 2023 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE IVTM THERAPY WAS PERFORMED ON A 68-YEAR-OLD FEMALE PATIENT TO INDUCE HYPOTHERMIA. THE COOL LINE CATHETER (LOT # 173265) WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN VEIN. AT THE START OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 37.6°C. ON (B)(6) 2023, THE NURSE NOTICED A LEAK AT THE DISTAL INFUSION LUERS CONNECTION. PER THE REPORTER, THE DISTAL INFUSION PORT WAS USED TO DELIVER THE NIMOTOP MEDICATION. THE LINE WAS DISCONNECTED, AND THE MEDICATION WAS SWITCHED TO THE PROXIMAL INFUSION LUER. ON (B)(6) 2023, ELEVEN DAYS AFTER THE LEAK INCIDENT, THE SECOND LEAK WAS OBSERVED AT THE PROXIMAL INFUSION LUMEN CONNECTION. THE CATHETER WAS REPLACED. THE THERAPY IS STILL ONGOING. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101823 ↗
• MalfunctionNov 28, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AS REPORTED, BLOOD-TINGED WAS NOTICED IMMEDIATELY IN THE TUBING OF THE START-UP KIT AS SOON AS THE CUSTOMER CONNECTED IT TO THE COOL LINE CATHETER (LOT #174009). THE CUSTOMER SUSPECTED A COOL LINE CATHETER LEAK. THE COOL LINE CATHETER INSERTION SITE WAS AT THE SUBCLAVIAN VEIN, AND THE INSERTING PHYSICIAN IS A FREQUENT USER WITH ZOLL PRODUCT. PER REPORTER, THE CATHETER WAS NOT REPLACED, AND THERE WAS NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED TO THE PATIENT. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875011 ↗
• MalfunctionOct 4, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE COOL LINE CATHETER (LOT # 162565) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN FOR THERAPEUTIC HYPOTHERMIA MANAGEMENT THERAPY. APPROXIMATELY 1 HOUR AFTER THE INITIATION OF THE TREATMENT, THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM. SUBSEQUENTLY, THE CONSOLE'S PUMP ROTOR STOPPED, AND THE SYSTEM WENT INTO STANDBY MODE. THE CUSTOMER NOTICED THAT THE 500-ML SALINE BAG WAS EMPTY. THE CUSTOMER STATED THAT THERE WERE NO ISSUES WITH THE START-UP KIT (SUK), AND ITS PINWHEEL WAS ROTATING AS INTENDED. THE CUSTOMER REPLACED THE SALINE BAG AND RESUMED TREATMENT. ABOUT 10-15 MINUTES LATER, THE STAFF CAME BACK TO THE ROOM AND OBSERVED THAT THE SECOND SALINE BAG WAS ALSO EMPTY. THE CUSTOMER DID NOT REPORT IF THE STAFF HEARD ANY ALARMS. THE THERMOGARD CONSOLE WAS STOPPED, AND THE CUSTOMER REPLACED THE SALINE BAG AGAIN. THE CUSTOMER REMOVED THE CATHETER AND INSPECTED THE START-UP KIT (SUK) TUBING TO TROUBLESHOOT THE ISSUE AND FIND THE SOURCE OF THE LEAK. BUT, NO EVIDENCE OF A LEAK WAS OBSERVED, AND THERE WAS NO CHANGE IN SALINE MENISCUS LEVEL, INDICATING THAT THERE WAS NO SALINE LEAK OR DROP IN SALINE LEVEL. THE CUSTOMER THEN RE-CONNECTED THE COOL LINE CATHETER TO THE THE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541348 ↗
• MalfunctionJul 29, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, CUSTOMER NOTICED BLOOD-TINGED FLOWING BACK INTO THE TUBING. A COOL LINE CATHETER (LOT #166245) WAS USED. TREATMENT WAS DISCONTINUED. NO ADDITIONAL INFORMATION WAS PROVIDED FROM CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 15132631 ↗
• InjuryJun 28, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY, THE CUSTOMER NOTED LEAK ON THE ICY CATHETER (LOT #UNKNOWN). THE PATIENT DEVELOPED PULMONARY EMBOLISM (PE) DURING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 14844578 ↗
• MalfunctionOct 20, 2021Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE PATIENT WAS ADMITTED FOR A MULTI-ORGAN HARVEST. ZOLL COOL LINE CATHETER (LOT #161437) WAS INSERTED BY A PHYSICIAN SMOOTHLY, AT THE FIRST ATTEMPT. THE COOL LINE CATHETER WAS UTILIZED DURING THE PATIENT PREPARATION FOR A CT SCAN. THE HIGH-PRESSURE PUMP WAS USED TO ADMINISTER THE CONTRAST AGENTS THROUGH THE DISTAL INFUSION PORT OF THE COOL LINE CATHETER. THE DISTAL INFUSION PORT TUBING BURST NEXT TO THE DISTAL LUER AFTER THE USER APPLIED THE CONTRAST FLUID. TO REDUCE THE RISK OF PULMONARY EMBOLISM, THE INFUSION LINE WAS CLAMPED AND UPON RETURN TO THE INTENSIVE CARE UNIT, THE KNOT WAS TIED AND A PLUG WAS FITTED TO THE LINE. FOLLOWING THIS, THE COOL LINE CATHETER WAS REPLACED AND THE REGULAR CENTRAL VENOUS CATHETER (CVC) LINE WAS PLACED. THE CUSTOMER STATED THAT THE CATHETER'S DISTAL LUMEN DID NOT RESIST TO THE PRESSURE DURING THE INJECTION OF THE CONTRAST PRODUCT AND THE DISTAL TUBING SPLIT IN TO TWO JUST BELOW THE LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12663211 ↗
• MalfunctionJun 25, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A COOL LINE CATHETER (LOT# UNKNOWN) WAS USED FOR IVTM THERAPY. IT WAS REPORTED THAT BLOOD WAS OBSERVED IN THE CATHETER BALLOON, WHICH IS AN INDICATION OF A POTENTIAL CATHETER LEAK. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE; THEREFORE, PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12064819 ↗
• MalfunctionApr 6, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY OF THE COVID-19 PATIENT, A COOL LINE CATHETER WAS PLACED IN A LEFT INTERNAL JUGULAR VEIN. THE INSERTION WAS SMOOTH. THE PATIENT'S INITIAL TEMPERATURE WAS 37.3°C WITH A TARGET OF 37.2°C. DURING THE COOLING PHASE, THREE DAYS AFTER THE TREATMENT STARTED, THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM AND THE 500ML SALINE BAG WAS NOTED ALMOST EMPTY. THE USER REPLACED THE SALINE BAG AND THE START-UP KIT (SUK), AND THE TREATMENT WAS RESUMED UTILIZING THE SAME CONSOLE. HOWEVER, THE SECOND 500ML BAG WAS ALSO NOTED LOSING THE FLUID VOLUME. PER THE PHYSICIAN'S REQUEST, THE TREATMENT WAS STOPPED AS THE PATIENT DID NOT REQUIRE MORE TEMPERATURE MANAGEMENT. THE COOL LINE CATHETER WAS NOT REMOVED AND WAS LEFT AS A CENTRAL LINE UNTIL THE SEVENTH DAY OF THE PATIENT'S TREATMENT. PER A REPORTER, THERE WERE NO TRACES OF FLUID OBSERVED ON THE CONSOLE, PATIENT'S BED, OR FLOOR AROUND THE PATIENT; THEREFORE, A CATHETER LEAK AND INFUSION OF ABOUT 350 - 400ML OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE COOL LINE CATHETER WAS DISCARDED BY THE CUSTOMER AS IT WAS USED TO TREAT A COVID-19 PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617389 ↗
• MalfunctionDec 13, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  A PATIENT WAS ADMITTED FOR FEVER CONTROL TREATMENT USING IVTM THERAPY. A COOL LINE CATHETER (LOT# 151301) WAS INSERTED INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN WITH NO UNUSUAL RESISTANCE NOTED. DURING THE COOLING PHASE, THE THERMOGARD SYSTEM GENERATED AN AIR TRAP ALARM, AND THE NURSE NOTICED THAT THE 500-ML SALINE BAG WAS EMPTY. THE DWELL TIME OF THE CATHETER WAS 72 HOURS WHEN THE ISSUE WAS NOTED. THE SALINE BAG WAS REMOVED, AND A 1000-ML SALINE BAG WAS PLACED. AFTER A SHORT PERIOD OF TIME, IT WAS NOTED THAT THE SECOND SALINE BAG WAS HALF EMPTY. THERE WERE NO TRACES OF FLUID OBSERVED ON THE THERMOGARD CONSOLE, PATIENT'S BED, OR FLOOR. DURING FURTHER INSPECTION, BLOOD TINGE WAS OBSERVED IN THE TUBING. THEREFORE, CATHETER LEAK AND INFUSION OF ABOUT 1000 TO 1500 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE CATHETER WAS REPLACED, AND THE IVTM TREATMENT CONTINUED SUCCESSFULLY WITH THE SAME THERMOGARD CONSOLE. THE DWELL TIME OF THE CATHETER WAS 144 HOURS AT THE TIME OF REMOVAL. NO MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE AND ON THE START-UP KIT (SUK). NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10998568 ↗
• MalfunctionOct 29, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AFTER 10 HOURS OF IVTM THERAPY, THE USER OBSERVED SALINE BAG WAS LOW AT APPROXIMATELY 250 ML. USER DID NOT OBSERVED ANY LEAKS AROUND THE PATIENT, BED SIDE OR CONSOLE; SUSPECTING A COOL LINE CATHETER (LOT#147000) LEAK. THE FOLLOWING DAY, AFTER THE PATIENT HAD COUGHING/VOMITTING EPISODE, THE SUK TUBING WAS OBSERVED WITH BLOOD IN IT, DISCONTINUED THE THERAPY, AND REMOVED THE CATHETER. NO CONSEQUENCES, OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10759994 ↗
• MalfunctionSep 15, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE 3RD DAY OF THE IVTM THERAPY, THE USER OBSERVED 500 ML OF EMPTY SALINE BAG. FOLLOWING THIS, ANOTHER 500 ML SALINE BAG WAS REPLACED AND AFTER AN UNSPECIFIED PERIOD OF TIME, THE USER NOTICED AN ALMOST EMPTY SALINE BAG. NO LEAK WAS OBSERVED ON THE FLOOR, AROUND THE CONSOLE OR ON THE BED AND NO BLOOD TINGE WAS NOTICED ON THE SUK TUBING. SUSPECTING COOL LINE CATHETER LEAK AND APPROXIMATELY 750 ML OF SALINE INFUSION. THE DWELL TIME OF THE CATHETER WAS APPROXIMATELY 60 HOURS. THE CATHETER WAS REPLACED AND IVTM THERAPY CONTINUED. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538781 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AS REPORTED, AFTER 4 DAY OF IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AIR TRAP ALARM AND THE USER REPLACED THE SALINE BAG. USER DID NOT OBSERVE ANY LEAK ON THE SUK AND NO LIQUID ON THE FLOOR, INDICATING A BALLOON LEAK ON THE COOLLINE CATHETER. THE USER OBSERVED SALINE BAG LOSES ABOUT 100 ML OF SALINE PER DAY. THE TARGET TEMPERATURE WAS 36°C AND THE TEMPERATE AT THE TIME OF ISSUE WAS 36°C. THE CATHETER WAS REPLACED AND THERAPY WAS CONTINUED. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869523 ↗
• MalfunctionJan 28, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY FOR A PATIENT WITH HYPOTHERMIA, THE USER OBSERVED EMPTY SALINE BAG AND NOTICED BLOOD FLOW FROM THE OUT LUER OF THE COOL LINE CATHETER (SN (B)(4)). SUSPECTING CATHETER LEAK. THE DWELL TIME OF THE CATHETER WAS 120 HOURS. THE PATIENT TEMPERATURE AT THE START OF THE THERAPY WAS 36.4°C. THE TARGET TEMPERATURE WAS 33°C AND THE TEMPERATURE AT THE TIME OF THE ISSUE WAS 36°C. THE CATHETER WAS NOT REMOVED AND WAS CONTINUED TO BE USED AS A CENTRAL VENOUS CATHETER. THE PATIENT TREATMENT WAS CONTINUED WITH ALTERNATE TEMPERATURE MANAGEMENT METHOD. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9640041 ↗
• MalfunctionFeb 27, 2019Use of Device Problem; Use of Device Problem

  DURING PATIENT IVTM THERAPY FOR FEVER MANAGEMENT, CUSTOMER REPORTED THAT THE SALINE BAG WAS EMPTY AFTER 2 HRS OF DWELL TIME. NO SALINE FLUID WAS OBSERVED ON THE FLOOR, CONSOLE OR PATIENT'S BED. CUSTOMER SUSPECTED THAT THE COOL LINE HEPARIN CATHETER (LOT #80765) MAY HAVE LEAKED. NO OTHER TEMPERATURE MANAGEMENT PROCEDURES PERFORMED. IT WAS NOTED THAT THE COOL LINE CATHETER WAS INSERTED SMOOTHLY INTO THE PATIENT'S LEFT INTERNAL JUGULAR VEIN. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8375008 ↗
• MalfunctionNov 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  A (B)(6) YEARS OLD MALE PATIENT ((B)(6) KG) WAS HOSPITALIZED AND UNDERWENT IVTM TREATMENT WITH TARGET TEMPERATURE SET TO 34°C DEGREE. COOL LINE CATHETER WAS INSERTED INTO THE INTERNAL JUGULAR LEFT VEIN BY A PHYSICIAN WITHOUT ISSUES. AFTER 26 HOURS OF THE TREATMENT, THE BLOOD WAS NOTED IN THE SUK AND CATHETER LEAK WAS SUSPECTED. THE TEMPERATURE WAS AT 34°C DEGREE WHEN THE ISSUE WAS NOTED. PER REPORTER, THE CATHETER WAS NOT REMOVED. NO OTHER TEMPERATURE MANAGEMENT PROCEDURES WAS PERFORMED. THE CURRENT CONDITION OF THE PATIENT IS INTUBATED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8035710 ↗
• MalfunctionNov 20, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED POST CARDIAC ARREST AND INTRAVASCULAR TEMPERATURE MANAGEMENT WAS NEEDED FOR FEVER MANAGEMENT. A ZOLL COOL LINE CATHETER WAS INSERTED INTO THE LEFT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. THE INSERTION WAS SMOOTH. THE INDWELL TIME OF THE CATHETER WAS SEVEN DAYS. ON THE SEVEN DAYS AFTER THERAPY WAS INITIATED, AN AIR TRAP ALARM WAS NOTED. THE CATHETER WAS REMOVED SINCE THE THERAPY WAS COMPLETED. THE PATIENT TEMPERATURE PRIOR TO THE IVTM THERAPY WAS 40 DEGREE CELSIUS. THE TARGET TEMPERATURE ON THE CONSOLE WAS 37 DEGREE CELSIUS. THE PATIENT'S TEMPERATURE HAS IMPROVED AND NO LONGER NEEDS AN IVTM THERAPY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047389 ↗