3M™ Ranger™ 24355Recalls & reported problems
3m Company · 3M™ Ranger™ Blood/Fluid Warming High Flow Set, 24355, 10/Case · Class 2
Quick summary
This 3M Ranger blood/fluid warming high flow set is a disposable tubing set used to warm and deliver blood and fluids during transfusion. Most of the 64 reports describe leaks and blood or fluid spilling from the tubing, often at the Y-connection, and spikes that feel loose and snap off or detach from the tubing during rapid infusion or when swapped between blood bags. None of the reports mention deaths or injuries, 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
- 64
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10707387792685), received between Feb 23, 2023 and Jun 2, 2026 — classified as 64 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (57 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak57
- Leak/Splash5
- Improper or Incorrect Procedure or Method2
- Detachment of Device or Device Component1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions64
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Fluid/Blood Leak
A USER FACILITY REPORTED THAT THE SPIKES ON 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS APPEARED LOOSER THAN EXPECTED AND WERE PRONE TO SNAPPING WHEN INSERTED INTO BLOOD BAGS. THE SPIKE DETACHED FROM THE TUBING DURING USE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25366312 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
A USER FACILITY REPORTED THE TUBING ON A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SEPARATED FROM THE SPIKE DURING RAPID INFUSION. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175164 ↗MalfunctionApr 7, 2026Fluid/Blood Leak
IT WAS REPORTED THE SPIKE ON TWO 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS DETACHED FROM THE TUBING WHEN THEY WERE CHANGING UNITS DURING A MASSIVE TRANSFUSION PROTOCOL. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811223 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
A USER FACILITY REPORTED TWO 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS WERE INEFFECTIVE IN TRANSFUSING BLOOD PRODUCTS AS THEY WERE COMPROMISED DURING INFUSION. THE FIRST SET ALLEGED THAT THE SPIKE PORT WAS TWISTED CAUSING AN OCCLUSION. UPON CORRECTING IT, THE SPIKE SEPARATED FROM THE TUBING. ADDITIONALLY, THE SPIKE SEPARATED FROM THE TUBING ON A SECOND SET WHEN ATTEMPTING TO REMOVE IT FROM THE BLOOD BAG. THE CUSTOMER LATER REPORTED THE SETS DID NOT LEAK BUT WOULD HAVE DUE TO THE SPIKES DISCONNECTING FROM THE TUBING. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700448 ↗MalfunctionMar 18, 2026Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE Y CONNECTION WHEN BLOOD WAS BEING ADMINISTERED UNDER PRESSURE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627426 ↗MalfunctionMar 6, 2026Fluid/Blood Leak
IT WAS REPORTED THE SPIKE ON APPROXIMATELY FIVE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS DETACHED FROM THE TUBING DURING RAPID TRANSFUSION OF BLOOD AND FLUIDS. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536275 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS LEAKED BLOOD WHEN THE CONNECTOR BROKE DURING INFUSION. THIS OCCURRED TWO DAYS IN A ROW. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED DUE TO THE ALLEGED MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500687 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
IT WAS REPORTED AFTER SETTING UP THE WARMER, FLUID LEAKAGE WAS OBSERVED FROM THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317190 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
A USER FACILITY REPORTED THE TUBING ON TWO 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS DISLODGED AT THE BASE ON THE SPIKE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316628 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE CASSETTE WHEN CHANGING THE BLOOD BAG. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316100 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SPIKE DISLODGED WHEN ADMINISTERING BLOOD PRODUCTS. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23822515 ↗MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED THAT THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET EXPERIENCED A LEAK AT THE LUER CONNECTION DURING USE. THE CONNECTIONS WERE REPORTEDLY PROPERLY TIGHTENED DURING SETUP. HOWEVER, ONE OF THE SCREW CAPS LOOSENED DURING ADMINISTRATION OF THE THIRD BLOOD BAG, RESULTING IN FLUID LEAKAGE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465526 ↗MalfunctionOct 20, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED THREE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS LEAKED WHILE USING A RAPID INFUSER. THERE WAS A CODE TRANSFUSION IN THE INTENSIVE CARE UNIT AND TWO DIFFERENT SETS OF TUBING SEPARATED AT THE SPIKE AND TUBE CONNECTION, RESULTING IN TWO STAFF MEMBERS GETTING BLOOD ON THEIR FACE. THIS ALSO OCCURRED DURING A CODE TRANSFUSION IN THE EMERGENCY DEPARTMENT EARLIER IN THE WEEK, RESULTING IN EXPOSURE TO A STAFF MEMBER. NO INJURIES OR MEDICAL INTERVENTIONS WERE INDICATED DUE TO THE ALLEGED MALFUNCTIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 22-SEP-2025 INDICATING THE LEAK IN THE EMERGENCY DEPARTMENT OCCURRED ON (B)(6) 2025. ISSUE REGARDING TWO LEAKS IN INTENSIVE CARE UNIT IS INVESTIGATED UNDER MDR 2110898-2025-00060. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335656 ↗MalfunctionSep 17, 2025Leak/Splash; Leak/Splash
A USER FACILITY REPORTED THREE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SETS LEAKED WHILE USING A RAPID INFUSER. THERE WAS A CODE TRANSFUSION IN THE INTENSIVE CARE UNIT AND TWO DIFFERENT SETS OF TUBING SEPARATED AT THE SPIKE AND TUBE CONNECTION, RESULTING IN TWO STAFF MEMBERS GETTING BLOOD ON THEIR FACE. THIS ALSO OCCURRED DURING A CODE TRANSFUSION IN THE EMERGENCY DEPARTMENT EARLIER IN THE WEEK, RESULTING IN EXPOSURE TO A STAFF MEMBER. NO INJURIES OR MEDICAL INTERVENTIONS WERE INDICATED DUE TO THE ALLEGED MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075240 ↗MalfunctionAug 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE CASSETTE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22924089 ↗MalfunctionAug 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
A NURSE REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED DURING PATIENT USE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22924029 ↗MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
A NURSE REPORTED THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET DISCONNECTED AT THE LEUR LOCK AFTER IT WAS TIGHTENED ON INITIATION. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835227 ↗MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
A NURSE REPORTED THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SPIKE SEPARATED FROM THE TUBING AND CAUSED BLOOD TO LEAK. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834569 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED THAT DURING A MASSIVE HEMORRHAGE PROTOCOL AROUND THE 18TH PRODUCT, THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SEPARATED AT THE SPIKE-TO-TUBING CONNECTION, LEAVING THE SPIKE IN THE BLOOD BAG. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22778104 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED THAT DURING AN ABDOMINAL ANEURYSM PROCEDURE, THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET SEPARATED AT THE SPIKE-TO-TUBING CONNECTION. THERE WERE NO REPORTED INJURIES OR MEDICAL INTERVENTIONS REQUIRED AS A RESULT OF THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777104 ↗MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED AFTER THIRTY MINUTES OF USE, 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED ON THE SEAM OF THE HEAT EXCHANGER WHILE ADMINISTERING BLOOD. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22399280 ↗MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED THE 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED AT THE CASSETTE WHEN THE SOLUTION BAG WAS PRESSURIZED. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22338972 ↗MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED DURING PRIMING, PRIOR TO PATIENT USE. THE LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE TUBING AND THE BUBBLE TRAP. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052942 ↗MalfunctionMar 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET LEAKED FROM A CRACK IN THE LEUR LOCK PORT PRIOR TO USE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634993 ↗MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED A 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET TUBING SEPARATED FROM THE SPIKES DURING AN AORTIC SURGICAL PROCEDURE. NO INJURIES OR MEDICAL INTERVENTIONS WERE REQUIRED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21517617 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.