Quattro, Heparin, Premium Kit, US IC-4593Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00849111075503), received between Jun 13, 2017 and Nov 7, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING REWARMING PHASE OF IVTM THERAPY, IT WAS NOTICED THAT THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM AND CUSTOMER NOTICED BLOOD IN THE START-UP-KIT TUBING AND THE 500ML SALINE BAG HAD EMPTIED. THE QUATTRO CATHETER (LOT #163925) SUSPECTED TO BE LEAKING. PATIENT TEMPERATURE WAS AT 98.1C DEGREES AND DECREASED TO 97.4C DEGREES WHEN THE BLOOD WAS NOTED IN THE START-UP-KIT. THE QUATTRO CATHETER WAS INSERTED SMOOTH INTO THE PATIENT'S LEFT FEMORAL VEIN. PER REPORTER, NO ISSUE WHEN REMOVING THE CATHETER, AND NO FLUID CAME OUT THE BALLOON. CATHETER DWELL TIME WAS 3 DAYS. THE CUSTOMER WAS ABLE TO CLEAR THE "AIR TRAP" MESSAGE AND THE THERMOGARD FUNCTIONING PROPERLY. WARMING BLANKETS WAS USED TO CONTINUE WITH TREATMENT, SINCE PATIENT HAD COMPLETED MOST OF THE REWARMING TREATMENT. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 12763921 ↗
• MalfunctionOct 3, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE CUSTOMER REPORTED THAT DURING IVTM THERAPY THE QUATTRO CATHETER (LOT# UNKNOWN) WAS PLACED IN THE LEFT FEMORAL VEIN. ON THE THIRD DAY, THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM, AND ONLY 100ML FLUID WAS OBSERVED INSIDE THE 500ML SALINE BAG AND THERE WAS A CONSIDERABLE AMOUNT OF AIR IN THE AIR TRAP. PER THE REPORTER, THE THERMOGARD CONSOLE IS FUNCTIONAL AFTER IT GENERATED AN AIR TRAP ALARM. THERE WERE NO SIGNS OF FLUID ON THE FLOOR UNDER OR BEHIND THE CONSOLE OR INSIDE OF THE AIR TRAP. THERE WAS SOME BLOOD PRESENT IN THE START-UP KIT (SUK) TUBING. IVTM THERAPY HAD BEEN COMPLETED AT THE TIME OF THE EVENT. SUSPECTING CATHETER LEAK AND 400 ML OF SALINE INFUSION. THE CUSTOMER WAS INSTRUCTED TO REMOVE THE CATHETER. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10624478 ↗
• MalfunctionJun 23, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AS REPORTED, THE QUATTRO CATHETER (LOT # UNKNOWN) WAS PLACED INTO THE PATIENT'S LEFT FEMORAL VEIN, AND A RIGHT RADIAL ARTERIAL LINE WAS ALSO PLACED FOR MEDICAL PURPOSES. DURING THE REWARMING PHASE, AFTER 6 HOURS INTO NORMOTHERMIA, THE NURSE NOTED THAT THE 500 ML SALINE (NS) BAG WAS EMPTY. THE USER REPLACED THE SALINE BAG AND THE TREATMENT RESUMED. HOWEVER, AFTER ABOUT 30 MINUTES, IT WAS NOTED THAT THE SALINE LEVEL IN THE SECOND BAG WAS ALSO DECREASING. AS PER USER, THERE WERE NO TRACES OF FLUID ON THE FLOOR, PATIENT'S BED, OR AROUND THE THERMOGARD CONSOLE. CATHETER LEAK AND INFUSION OF AT LEAST 500 MILLILITERS OF SALINE WERE SUSPECTED. THERE WAS NO BLOOD TINGE IN THE TUBING. THE CATHETER WAS REPLACED AND THE PATIENT TREATMENT WAS COMPLETED SUCCESSFULLY WITH THE SAME THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187130 ↗
• MalfunctionApr 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  DURING IVTM THERAPY, NURSE REPORTED THAT THE PATIENT'S TEMPERATURE WAS RISING AND THAT THE PIN WHEEL ON THE START-UP KIT (SUK) WAS NOT SPINNING. A ZOLL CLINICAL REPRESENTATIVE PROVIDED TROUBLESHOOTING GUIDELINES OVER THE PHONE WITH NO SUCCESS. ZOLL CLINICAL REPRESENTATIVE THEN WENT TO THE FACILITY AND DISCONNECTED THE SUK FROM THE PATIENT AND CONNECTED IT TO ITSELF AND PRESSED THE RUN BUTTON, PIN WHEEL STARTED TO SPIN. ALL THREE CENTRAL LINE PORTS FLUSHED WITH SALINE AND WAS ABLE TO DRAW BACK BLOOD WITH NO PROBLEMS. ALSO, THE BALLOON LUERS WERE FLUSHED WITH 2ML OF SALINE AND FELT A SLIGHT RESISTANCE. THE SUK WAS RECONNECTED BACK TO THE PATIENT BUT PINWHEEL DID NOT SPIN. SALINE FLUID SLOWLY MOVING THROUGH THE TUBING. THE INSERTION OF THE SOLEX CATHETER WAS SMOOTH BY A EXPERIENCE PHYSICIAN. THE TUBING GOING INTO THE "IN" LUER WAS COOL TO THE TOUCH, BUT THE "OUT" LUER WAS WARM. THE BALLOON WAS DIFFICULT TO SEE ON THE X-RAY. THE PHYSICIAN EXCHANGED THE SOLEX 7 CATHETER WITH A REGULAR CENTRAL LINE TO CONTINUE WITH IVTM THERAPY. THE NURSE STATED THAT THERE WAS NO PROBLEMS WITH CATHETER REMOVAL AND DWELL TIME WAS 24 HOURS. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003015 ↗
• MalfunctionOct 2, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED, DURING PATIENT IVTM THERAPY, THE USER FACILITY NURSE NOTICED LESS THAN 100CC LEFT IN SALINE BAG WITHIN THE LAST HOUR. NO FLUID ON THE FLOOR, AROUND MACHINE OR IN PATIENT'S BED WAS OBSERVED. THE SOLEX 7 CATHETER (LN UNKNOWN) WAS REMOVED AND REPLACED WITH A NEW CATHETER TO CONTINUE WITH THE THERAPY. NO CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928309 ↗
• MalfunctionAug 29, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, A (B)(6) POUNDS (B)(6) YEARS OLD MALE WAS HOSPITALIZED FOR POST CARDIAC ARREST. THE PATIENT HAD A SMOOTH INSERTION OF THE SOLEX 7 CATHETER (LOT NUMBER UNKNOWN) THROUGH THE LEFT INTERNAL JUGULAR. AFTER 72 HOURS (3 DAYS) OF DWELL TIME, AT 4:45 AM, THE USER'S FACILITY NURSE WAS GIVEN ORDER TO GIVE BOLUS OF 1 LITER NORMAL SALINE TO THE PATIENT AND AT 5:30 AM, THE NURSE NOTICED PURPLE SWELLING ON THE LEFT SIDE FACE OF THE PATIENT. THERAPY STOPPED IMMEDIATELY AND SOLEX 7 CATHETER WAS REMOVED. ICY CATHETER WAS PLACED IN THE PATIENT'S LEFT FEMORAL VEIN TO CONTINUE WITH THERAPY. ICY CATHETER HAD BEEN USED FOR PRESSOR AND COOLING FOR ADDITIONAL 3 DAYS WITHOUT ANY ISSUE. BASED ON ZOLL MEDICAL SAFETY ASSESSMENT, THE PURPLE SWELLING ON THE LEFT SIDE FACE OF THE PATIENT WAS RELATED TO USE ERROR, THE FACILITY NURSE DID NOT INSERT THE SOLEX 7 CATHETER FAR ENOUGH. ZOLL HAS RECOMMENDED FOR CUSTOMER RE-TRAINING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7830546 ↗
• MalfunctionAug 29, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED, DURING SOLEX 7 CATHETER (LOT NUMBER UNKNOWN) INSERTION ON A PATIENT, CUSTOMER OBSERVED CATHETER'S TIP TORE OFF. A NEW CATHETER WAS PLACED ON THE PATIENT AND THERAPY CONTINUED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7830537 ↗
• MalfunctionJan 31, 2018Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT, HOSPITALIZED FOR POST CARDIAC ARREST, WAS RECEIVING TEMPERATURE MANAGEMENT THERAPY FOR THERAPEUTIC HYPOTHERMIA. A ZOLL CATHETER (TYPE NOT SPECIFIED) WAS PLACED IN PATIENT'S FEMORAL VEIN; THERE WERE NO REPORTS OF ANY COMPLICATIONS AT THE TIME OF PLACEMENT. AT AN UNKNOWN TIME DURING THERAPY, THE ATTENDING NURSE NOTICED THAT THE SALINE BAG WAS LOSING FLUID AND INDICATED THE THERMOGARD XP IVTM CONSOLE DID NOT ALARM. SEVERAL HOURS AFTER THE SALINE BAG WAS REPLACED, THE NIGHT SHIFT NURSE NOTED THE SECONDARY BAG WAS LOSING FLUID. PER NURSE, THERE WERE NO SIGNS OF FLUID ON THE PATIENT'S BED OR FLOOR AND AFTER FLUSHING THE PORTS, NO BLOOD FOUND IN THE LURES. AT THE RECOMMENDATION FROM THE ZOLL CLINICAL SPECIALIST, THE START-UP KIT AND SALINE BAG WERE REPLACED. APPROXIMATELY 2.5 HOURS LATER, THE ATTENDING NURSE NOTICED THAT THE SALINE BAG LOST 100CC OF FLUID. THE ZOLL CLINICAL SPECIALIST RECOMMENDED A CATHETER REPLACEMENT; HOWEVER, THE EVENING EMERGENCY DEPARTMENT DOCTOR WAS UNAVAILABLE TO PERFORM THE REPLACEMENT. THE ZOLL CLINICAL SPECIALIST WAS INFORMED THE FOLLOWING MORNING THAT THE PATIENT CONTINUED TO RECEIVE TEMPERATURE MANAGEMENT THERAPY WITH THE THEMOGARD XP IVTM SYSTEM AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7230451 ↗
• MalfunctionJan 12, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS INSERTED A QUATTRO CATHETER WITHOUT ISSUE AND RECEIVED IVTM THERAPY. APPROXIMATELY 20 HOURS INTO TREATMENT, THE THERMOGARD CONSOLE (SN (B)(4)) DISPLAYED AN AIRTRAP ALARM. UPON EXAMINATION, THE USER OBSERVED SIGNS OF LEAK AROUND THE PATIENT'S BEDSIDE LIKELY CAUSED BY A LEAK ON THE CATHETER OR START-UP KIT (SUK); HOWEVER, COULD NOT BE CONCLUSIVELY DETERMINED AND A CATHETER LEAK COULD NOT BE RULED OUT AT THIS TIME. SINCE THE TARGET TEMPERATURE OF 34°C HAD ALREADY BEEN ACHIEVED, THE CATHETER WAS REMOVED FROM THE PATIENT AND NO FURTHER TEMPERATURE MANAGEMENT WAS ADMINISTERED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THIS REFERENCES THE REPORT OF A SUSPECTED LEAK ON THE CATHETER. REFERENCE MFR 3010617000-2018-00035 FOR THE REPORT OF AN AIRTRAP ALARM ON THE THERMOGARD CONSOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187822 ↗
• MalfunctionSep 19, 2017Leak/Splash; Device Operates Differently Than Expected; Leak/Splash; Device Operates Differently Than Expected

  A PATIENT WAS HOSPITALIZED AND UNDERWENT TREATMENT FOR HYPOTHERMIA. A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN BY A PHYSICIAN. 24 HOURS AFTER INITIATION OF THERAPY, BLOOD WAS NOTED INSIDE THE START-UP KIT (SUK). THE CATHETER WAS REPLACED AND THERAPY WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6877886 ↗
• MalfunctionAug 1, 2017Leak/Splash; Leak/Splash

  AS REPORTED, A QUATTRO CATHETER WAS INSERTED AFTER ABOUT 6 TO 12 HOURS INTO IVTM THERAPY, THE THERMOGARD CONSOLE DISPLAYED AN AIR TRAP ALARM. UPON INSPECTION, THE SALINE BAG WAS OBSERVED EMPTY. NO PHYSICAL SIGNS OF LEAK ON THE FLOOR AND ON THE PATIENT'S BEDSIDE WAS OBSERVED. THE HOSPITAL PERSONNEL EVENTUALLY EXCHANGED TO ANOTHER QUATTRO CATHETER TO COMPLETE THE IVTM TREATMENT. NO ADJUNCTIVE TEMPERATURE MANAGEMENT WAS PERFORMED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6757475 ↗
• MalfunctionJul 17, 2017Leak/Splash; Leak/Splash

  A POST CARDIAC ARREST PATIENT WAS INSERTED A QUATTRO CATHETER WITHOUT ISSUE IN THE FEMORAL VEIN FOR THERAPEUTIC HYPOTHERMIA. IT WAS REPORTED BY THE HOSPITAL NURSE THAT DURING DAY 3 INTO IVTM TREATMENT (MAINTENANCE PHASE), THE SALINE BAG WAS OBSERVED TO BE EMPTY AND THE THERMOGARD CONSOLE DISPLAYED AN AIRTRAP ALARM. UPON INSPECTION, NO TRACE OF BLOOD WAS OBSERVED IN THE START-UP KIT INCLUDING EVIDENCE OF LEAK AND NO ISSUE WAS FOUND ON THE THERMOGARD CONSOLE. THE NURSE REPLACED THE START-UP KIT; HOWEVER, THE SAME ISSUE WAS OBSERVED. FOLLOWING THIS THE DOCTOR DECIDED TO REMOVE THE CATHETER FROM THE PATIENT SINCE THE IVTM THERAPY IS ALREADY IN ITS MAINTENANCE PHASE. NO ADJUNCT THERAPY WAS ADMINISTERED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6720288 ↗
• InjuryJun 13, 2017Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A QUATTRO CATHETER WAS PLACED INTO THE ARTERY IN RIGHT GROIN. AT NIGHT, THE PATIENT'S RIGHT LEG WAS MOTTLED AND HAD NO PULSES. A WHITE FLUID DISCHARGE WAS SEEN AROUND CATHETER INSERTION. HOWEVER, THE CUSTOMER STATED THAT THE PATIENT WAS ON A DIPRIVAN DRIP WHICH IS WHITE IN COLOR. PER THE PHYSICIAN ORDER, THE CATHETER WAS REMOVED. ULTRASOUND OF LEG SHOWED OCCLUSION AND REQUIRED INTERVENTION. THE PHYSICIAN WHO COMPLETED THE INTERVENTION BELIEVES THE MOTTLED SKIN WAS DUE TO ARTERIAL PLACEMENT. THE PATIENT EXPIRED DUE TO REASONS UNRELATED TO THE CATHETER. PATIENT HAD A FEW COMORBIDITIES AND THAT GAVE HER A DECREASED ABILITY TO SURVIVE. THE CUSTOMER DID NOT ATTRIBUTED THE CATHETER TO THE PATIENT DEATH, AND AGREES THAT THIS WAS A USER ERROR. THE QUATTRO CATHETER IS INDICATED ONLY FOR THE FEMORAL PLACEMENT AND IT IS NOT TO BE PLACED IN ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6637289 ↗