TruSteelRecalls & reported problems across all models

We found 5 models of TruSteel by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 4,387 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2018 and Sep 30, 2026 — classified as 813 injuries, 3,574 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1,280 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TruSteel problems

TruSteel models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TruSteel™ 1002833

  Set, Administration, Intravascular
  2,948 reports
• TruSteel™ 1002835

  Set, Administration, Intravascular
  659 reports
• TruSteel™ 1002834

  Set, Administration, Intravascular
  582 reports
• TruSteel™ 1002836

  Set, Administration, Intravascular
  191 reports
• TruSteel™ 1000289

  Set, Administration, Intravascular
  7 reports

Recent TruSteel adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Unomedical A/S products

• Autosoft XC11 models · 31,720 reports
• MiniMed Infusion Sets58 models · 30,240 reports
• Medtronic Extended27 models · 22,785 reports
• Autosoft9021 models · 20,579 reports · 1 recall
• Minimed Quick-set18 models · 16,559 reports
• MiniMed Mio Advance12 models · 11,094 reports
• Autosoft307 models · 3,945 reports
• inset13 models · 2,869 reports