TruSteel™ 1002833Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
Quick summary
This Unomedical TruSteel single-use infusion set has 2,617 adverse event reports, with no deaths and 450 injuries. Reports mostly describe blocked flow and occlusion alarms, adhesive that fails to stick, leaks, and tubing that bends or comes apart early. Many reports also mention high blood sugar and diabetic ketoacidosis in patients. 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
- 2,948
- Deaths reported
- 0
- Injuries reported
- 584
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,948 adverse event reports that list this exact device (DI 05705244018426), received between Jan 18, 2021 and Sep 30, 2026 — classified as 584 injuries, 2,364 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (797 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
- Infusion or Flow Problem797
- Loss of or Failure to Bond518
- Leak/Splash287
- Detachment of Device or Device Component264
- Material Twisted/Bent250
- Premature Separation248
- Complete Blockage175
- Appropriate Device Problem Term/Code Not Available123
Patient problems
- No Clinical Signs, Symptoms or Conditions1,701
- Hyperglycemia1,034
- Elevated Ketones/ Diabetic Ketoacidosis162
- Hemorrhage/Blood Loss/Bleeding25
- Skin Infection13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Unspecified Infection9
- Pain8
Recent adverse event reports
The 25 most recent of 2,948 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949100 ↗MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949099 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that six infusion sets exhibited a blockage at the coupling housing connection during setup on (b)(6) 2026, preventing insulin flow into the infusion set despite insulin flowing through the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949096 ↗MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949094 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that six infusion sets exhibited a blockage at the coupling housing connection during setup on (b)(6) 2026, preventing insulin flow into the infusion set despite insulin flowing through the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949092 ↗InjurySep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannulas with seven infusion sets between 48 and 72 hours after insertion, reported on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948989 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that six infusion sets exhibited a blockage at the coupling housing connection during setup on (b)(6) 2026, preventing insulin flow into the infusion set despite insulin flowing through the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948969 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948958 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948953 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948752 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannulas with seven infusion sets between 48 and 72 hours after insertion, reported on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948750 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948749 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948738 ↗MalfunctionSep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced recurrent occlusion alarms associated with a bent infusion set needle at the infusion site, resulting in elevated blood glucose levels and a red bump at the insertion site on (b)(6) 2026.
Patient problems: Hyperglycemia; Rash
MAUDE report 50948734 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported one adhesive issue by the patient that was infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946096 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6)2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945316 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6)2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945314 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6) 2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945313 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6) 2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945310 ↗MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
It was reported that boxes containing infusion sets were found damaged during inbound receipt on 28 Aug 2026 following transfer between logistics providers. The damage involved both the outer and inner boxes and resulted in damage to the infusion set products.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944136 ↗MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
It was reported that boxes containing infusion sets were found damaged during inbound receipt on (b)(6) 2026 following transfer between logistics providers. The damage involved both the outer and inner boxes and resulted in damage to the infusion set products.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944133 ↗MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
It was reported that the patient faced an event where pallet configuration issues causing bottom layer crushed outer cartons affecting the product outer cartons in this shipment.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944130 ↗MalfunctionSep 30, 2026Failure to Fire
It was reported that the patient faced an event where infusion set did not deploy from the applicator during insertion attempt on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944107 ↗MalfunctionSep 30, 2026Failure to Fire
It was reported that the patient faced an event where infusion set did not deploy from the applicator during insertion attempt on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944080 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
It was reported that patient faced an event of blockage at the infusion set site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942852 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.