TruSteel™ 1002834Recalls & 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 TruSteel infusion set from Unomedical is a single-use tubing set for delivering medicine under the skin. The FDA database holds 544 reports for it, many describing flow problems, detachment and leaks, and some mentioning high blood sugar. There were 67 injuries and no deaths. 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
- 582
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 582 adverse event reports that list this exact device (DI 05705244018457), received between Apr 16, 2021 and Sep 29, 2026 — classified as 84 injuries, 498 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (167 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 Problem167
- Loss of or Failure to Bond143
- Detachment of Device or Device Component69
- Leak/Splash61
- Complete Blockage28
- Material Twisted/Bent26
- Premature Separation25
- Adverse Event Without Identified Device or Use Problem16
Patient problems
- No Clinical Signs, Symptoms or Conditions361
- Hyperglycemia181
- Elevated Ketones/ Diabetic Ketoacidosis24
- Hypoglycemia5
- Unspecified Infection5
- Rash3
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 582 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannulas event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928153 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannulas event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928150 ↗InjurySep 24, 2026Complete Blockage
It was reported that the patient experienced infusion set blockage at site causing high blood glucose levels correction via insulin injection event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50881668 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event of infusion sets fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878654 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event of infusion sets fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878652 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event of infusion sets fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878645 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event of infusion sets fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878639 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878548 ↗MalfunctionSep 24, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced recurrent occlusion events associated with bent infusion set needles between (b)(6) 2025 and (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877544 ↗MalfunctionSep 24, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced recurrent occlusion events associated with bent infusion set needles between (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877538 ↗MalfunctionSep 24, 2026Complete Blockage
It was reported that the patient experienced Intermittent clogs in the infusion set tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877422 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose level treated with multiple daily injections due to bleeding at infusion set insertion site on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50869354 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose level treated with multiple daily injections due to bleeding at infusion set insertion site on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50869345 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where infusion set tubing was leaking at the site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867780 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where infusion set tubing was leaking at the site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867775 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where infusion set tubing was leaking at the site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867637 ↗MalfunctionSep 18, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827865 ↗MalfunctionSep 18, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825076 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50822393 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50822193 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50822186 ↗InjurySep 16, 2026Complete Blockage
It was reported that patient faced infusion set occlusion issue, the blockage was located in the tubing. The blood glucose level was high and the patient was treated with correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50785243 ↗MalfunctionSep 15, 2026Partial Blockage
It was reported by the patient that occlusion and the blockage is likely at the site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771242 ↗InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient insulin flow blocked which leads to high blood glucose and Correction injection via Multiple Daily Injections.
Patient problems: Hyperglycemia
MAUDE report 50727030 ↗InjurySep 11, 2026Biocompatibility
It was reported that the patient experienced high blood glucose which was addressed by Correction injection using multiple daily injections as patient's abdomen very lean, limited areas with adequate adipose tissue on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50726456 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.