Level 1 DI-300Recalls & reported problems

Quick summary

This ICU Medical Level 1 DI-300 is a disposable set for warming blood and plasma fluids during infusion. The 44 reports describe leaking fluid or blood, hoses cracking, missing parts, and boxes arriving damaged, mostly discovered when the package was opened. No deaths and no injuries were reported, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 44
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 20695085430015), received between May 18, 2020 and Apr 13, 2023 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Fluid/Blood Leak22
Leak/Splash15
Component Missing4
Device Damaged Prior to Use3

Patient problems

No Clinical Signs, Symptoms or Conditions43
No Patient Involvement1

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TWO LOTS WERE RETURNED DUE TO HOSE BREAKAGE DISCOVERED UPON OPENING. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16734064 ↗
MalfunctionApr 13, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TWO LOTS WERE RETURNED DUE TO HOSE BREAKAGE DISCOVERED UPON OPENING. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16734045 ↗
MalfunctionApr 7, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED OF A DEVICE MALFUNCTION (WATER LEAK). DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704311 ↗
MalfunctionApr 7, 2023Component Missing; Component Missing
IT WAS REPORTED THAT DEVICE HAD MISSING COMPONENTS. DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704203 ↗
MalfunctionApr 7, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED OF A DEVICE MALFUNCTION (WATER LEAK). DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704191 ↗
MalfunctionApr 7, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE DEVICE ARRIVED DAMAGED. DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704188 ↗
MalfunctionApr 7, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THERE WAS A MALFUNCTION (PACKAGE). DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702567 ↗
MalfunctionApr 7, 2023Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THERE WAS A MALFUNCTION (PACKAGE). DISCOVERED UPON OPENING. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702519 ↗
MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE HAD A LEAKAGE PROBLEM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15709039 ↗
MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE HAD A LEAKAGE PROBLEM. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15708657 ↗
MalfunctionOct 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE IS A CHAMBER LEAKAGE PROBLEM. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657678 ↗
MalfunctionOct 24, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS A CHAMBER LEAKAGE PROBLEM AND RECOGNITION FAILURE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657644 ↗
MalfunctionOct 23, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS A LEAK AND LOSS OF FLUID FROM DRIP CHAMBER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15656428 ↗
MalfunctionOct 23, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN SET WAS PUT UNDER PRESSURE THERE WAS A LEAK. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15656426 ↗
MalfunctionOct 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE IS A LEAKAGE PROBLEM. DISCOVERED UPON OPENING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15567075 ↗
MalfunctionOct 7, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS A LEAKAGE PROBLEM AND IT WAS DISCOVERED UPON OPENING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15566593 ↗
MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE HAD A LEAKAGE PROBLEM. ISSUE WAS DISCOVERED UPON OPENING, NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113566 ↗
MalfunctionJun 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE LIQUID LEAKS OUT AT THE MIDDLE GLUING POINT OF THE 3 SUPPLY LINES TO THE DRIP CHAMBER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14757850 ↗
MalfunctionJun 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697574 ↗
MalfunctionJun 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697389 ↗
MalfunctionJun 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14677449 ↗
MalfunctionJun 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14677173 ↗
MalfunctionJun 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676962 ↗
MalfunctionJun 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO INJURY OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676807 ↗
MalfunctionJun 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE ASSEMBLY OF THE SET, LEAKS WERE NOTICED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676793 ↗

Device details

UDI-DI	`20695085430015`
Brand	Level 1
Model	DI-300
Company	Icu Medical, Inc.
Product code	KZL · DEVICE, WARMING. BLOOD AND PLASMA
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 16, 2025

Device type (GMDN): Convection blood/fluid warmer, high-flow

An electrically-powered device designed for in-line heating of rapidly-infused (may exceed 1 L/min) banked blood, blood products, and intravenous (IV) solutions (crystalloid and colloid), typically from about 4ºC to near body temperature (i.e., 35 to 37ºC), during high-blood-loss surgical procedures and for burn and trauma cases. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.