Start-Up Kit Custom Luer CG-500DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849111075336), received between Sep 29, 2017 and Sep 12, 2024 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K014241); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024

  TTM THERAPY (TARGETED TEMPERATURE MANAGEMENT) RUNNING AS ORDERED SINCE 0845; AT APPROXIMATELY 1000, RN (REGISTERED NURSE) NOTED FLUID IN TUBING AND IV BAG TO BE YELLOW IN COLOR, WAS PREVIOUSLY CLEAR; TTM THERAPY STOPPED, PROVIDER NOTIFIED; ZOLL CLINICAL REP NOTIFIED AND INSTRUCTED TO REMOVE START-UP KIT/TUBING AND REINITIATE THERAPY WITH A NEW KIT AND NEW IV BAG; CATHETER CHECKED PER CLINICAL REP DIRECTIONS WITH NO ISSUES NOTED, NO BLOOD NOTED WITH PULLING BACK ON THE CATHETER ''IN" PORT WITH DESIGNATED SYRINGE; NEW START KIT PRIMED AND SET UP AND THERAPY RE-INITIATED WITH NO ISSUES; PER INSTRUCTION, START-UP KIT AND FLUID BAG SAVED IN BIOHAZARD BAG TO SEND TO THE COMPANY FOR INSPECTION. MANUFACTURER RESPONSE FOR SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING, START-UP KIT CUSTOM LUER (PER SITE REPORTER). NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199121 ↗
• DeathJun 14, 2022Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING IVTM THERAPY ON A 59 YEAR OLD MALE POST CARDIAC ARREST PATIENT, THE CUSTOMER REPORTED THERE WAS A LEAK OBSERVED FROM THE AIR TRAP OF THE START-UP KIT (SUK) (LOT #173284). THE THERMOGARD XP IVTM SYSTEM DISPLAYED AN AIR TRAP ALARM. THE SUK WAS REPLACED AND THE ALARM WAS CLEARED. THE THERAPY WAS CONTINUED ON THE SAME CONSOLE WITHOUT ISSUE. THE DWELL TIME WAS 32 HOURS. PER THE CUSTOMER, THE PATIENT DIED, AND THE OUTCOME WAS NOT RELATED TO THE IVTM CONSOLE.

  Patient problems: Insufficient Information

  MAUDE report 14691197 ↗
• MalfunctionMay 5, 2021Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING THE IVTM THERAPY, CUSTOMER NOTICED THAT THE 500ML NORMAL SALINE BAG GOT EMPTIED AND NO TRACES OF SALINE FLUID WAS OBSERVED ON THE CONSOLE, ON THE PATIENT BED, OR ON THE FLOOR. THE THERMOGARD IVTM SYSTEM GENERATED AN "AIRTRAP" ALARM. PER REPORTER, THE AIRTRAP ALARM WAS CLEARED AND THERMOGARD SYSTEM IS FUNCTIONING PROPERLY. THE CUSTOMER SUSPECTS A LEAK FROM THE ICY CATHETER (LOT #155014).THE CATHETER INSERTION WAS SMOOTH AND DWELL TIME WAS 2 DAYS. THE PHYSICIAN DECIDED TO DISCONTINUE THE IVTM THERAPY BECAUSE THE PATIENT WAS IN GOOD CONDITION AND THE IVTM THERAPY WAS NO LONGER REQUIRED. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781081 ↗
• MalfunctionSep 29, 2017Leak/Splash; Leak/Splash

  AS REPORTED DURING PATIENT USE, 28 TO 30 HOURS AFTER THE CATHETER WAS PLACED INTO THE PATIENT BODY, THE CONSOLE EXHIBITED AN AIR TRAP ALARM, BLOOD WAS NOTED ON THE SALINE BAG AND A LEAK WAS SUSPECTED. THE SUK AND CATHETER WAS REMOVED HOWEVER WERE NOT REPLACED. NO PATIENT HARM OR CONSEQUENCE WAS REPORTED. REFERENCE MFR # 3010617000-2017-00821 FOR CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014241. One submission often covers many models, so check the product and lot details in each record.

• Z-0503-2007 · Jan 1, 2007 · Terminated
  Alsius Cool Line Catheter, Model CL-2295AE
• Z-0502-2007 · Jan 1, 2007 · Terminated
  Alsius Cool Line Catheter, Model CL-2295A
• Z-0369-06 · Nov 9, 2005 · Terminated
  Alsius CoolGard Temperature Regulation System
• Z-1397-05 · Jul 25, 2005 · Terminated
  Alsius CoolGard 3000 Temperature Regulation System
• Z-0258-05 · Nov 10, 2004 · Terminated
  Alsius CoolGard 3000 patient temperature regulation system
• Z-1159-04 · Jun 21, 2004 · Terminated
  Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000