TruSteel™ 1002835Recalls & 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 is a single-use tube that delivers insulin under the skin. Many of the 591 reports describe flow problems, leaks, and parts coming loose or detaching, and many mention high blood sugar in patients. The reports include 74 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
- 659
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 659 adverse event reports that list this exact device (DI 05705244018488), received between Dec 8, 2020 and Sep 29, 2026 — classified as 119 injuries, 540 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (228 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 Problem228
- Loss of or Failure to Bond94
- Leak/Splash72
- Detachment of Device or Device Component67
- Complete Blockage39
- Appropriate Device Problem Term/Code Not Available34
- Premature Separation29
- Device Handling Problem25
Patient problems
- No Clinical Signs, Symptoms or Conditions391
- Hyperglycemia239
- Elevated Ketones/ Diabetic Ketoacidosis21
- Hemorrhage/Blood Loss/Bleeding6
- Skin Infection4
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 25 most recent of 659 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50932586 ↗InjurySep 29, 2026Device Handling Problem
It was reported that the patient faced 4 infusion set issue related to an irritated insertion site on (b)(6) 2026, leading to high blood glucose, and patient also reported hospitalization from (b)(6)-2026 due to an infusion set issue.
Patient problems: Hyperglycemia
MAUDE report 50932286 ↗InjurySep 29, 2026Device Handling Problem
It was reported that the patient faced 4 infusion set issue related to an irritated insertion site on (b)(6) 2026, leading to high blood glucose, and patient also reported hospitalization from (b)(6) 2026 due to an infusion set issue.
Patient problems: Hyperglycemia
MAUDE report 50932228 ↗InjurySep 29, 2026Device Handling Problem
It was reported that the patient faced 4 infusion set issue related to an irritated insertion site on (b)(6) 2026, leading to high blood glucose, and patient also reported hospitalization from(b)(6) 2026 to (b)(6) 2026 due to an infusion set issue.
Patient problems: Hyperglycemia
MAUDE report 50932117 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced recurrent falling off of every infusion set during use since starting the pump on (b)(6) 2023, leading to high blood glucose levels above 500 mg/dL, which was treated with correction injections via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50931309 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced recurrent falling off of every infusion set during use since starting the pump on (b)(6) 2023, leading to high blood glucose levels above 500 mg/dL, which was treated with correction injections via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50931308 ↗MalfunctionSep 29, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931245 ↗MalfunctionSep 29, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931135 ↗MalfunctionSep 29, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931091 ↗InjurySep 29, 2026Device Handling Problem
It was reported that the patient faced high blood glucose 583 mg/dl treated with correction bolus via pump, event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50929946 ↗InjurySep 29, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50929663 ↗InjurySep 29, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50929568 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928648 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909959 ↗InjurySep 27, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909851 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909475 ↗InjurySep 24, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient faced infusion set steel cannula was bent on (b)(6) 2026. The blood glucose level was high at the time of event, and the patient was treated by correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50881673 ↗MalfunctionSep 24, 2026Complete Blockage
It was reported that the patient faced an event where the blockage was in the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877539 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877264 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set fell off during use (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865024 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient visited to emergency room due to hyperglycemia of 442 mg/dl with diabetic ketoacidosis caused by repeated occlusion alarms on (b)(6) 2026 which was treatment with IV and fluids of saline and insulin.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50864094 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient was hospitalized due to hyperglycemia with subsequent diabetic ketoacidosis caused by repeated occlusion alarms on (b)(6)2026 which was treated with manual insulin injections.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50864086 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced repeated occlusion alarms which led up hyperglycemia event on (b)(6) 2026 which was treated with insulin injections.
Patient problems: Hyperglycemia
MAUDE report 50864083 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced repeated occlusion alarms which led up hyperglycemia event on (b)(6) 2026 which was treated with insulin injections.
Patient problems: Hyperglycemia
MAUDE report 50864028 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient visited to emergency room due to hyperglycemia of 442 mg/dl with diabetic ketoacidosis caused by repeated occlusion alarms on (b)(6) 2026 which was treatment with IV and fluids of saline and insulin.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50864024 ↗
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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.