TruSteel™ 1002836Recalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical TruSteel infusion set is a single-use tube set that delivers insulin under the skin from a pump. Many of its 188 reports describe blocked or interrupted flow, parts coming off, and bent tubing. Some reports note high blood sugar, and a few mention diabetic ketoacidosis. There are 22 injury reports and no deaths. No recalls name this device. Reports fell from 68 in the year before to 28 in the latest year.
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
- 191
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 05705244018518), received between Nov 15, 2021 and Sep 15, 2026 — classified as 24 injuries, 167 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (88 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 Problem88
- Detachment of Device or Device Component27
- Material Twisted/Bent21
- Leak/Splash15
- Loss of or Failure to Bond15
- Device Handling Problem6
- Fluid/Blood Leak6
- Use of Incorrect Control/Treatment Settings6
Patient problems
- No Clinical Signs, Symptoms or Conditions129
- Hyperglycemia50
- Elevated Ketones/ Diabetic Ketoacidosis8
- Skin Inflammation/ Irritation3
- Hemorrhage/Blood Loss/Bleeding1
- Tissue Breakdown1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Handling Problem
It was reported that the patient experienced elevated blood glucose due to using the abdomen as the only infusion set insertion site, leading to an occlusion, and was treated with a correction bolus via Multiple Daily Injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50767569 ↗InjurySep 15, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced elevated blood glucose over 590 mg/dL due to using the infusion set for more than two days, leading to an occlusion, and was treated with a correction injection via Multiple Daily Injection on (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50767564 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590814 ↗InjuryAug 6, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50158081 ↗InjuryAug 6, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50157750 ↗InjuryAug 6, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50157742 ↗InjuryAug 6, 2026Leak/Splash
It was reported that patient faced four infusion sets tubing was leaking at the site on (b)(6) 2025. The patient experienced high blood glucose levels and event was resolved by correction injection via MDI.
Patient problems: Hyperglycemia
MAUDE report 50157578 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151847 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151841 ↗MalfunctionAug 6, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151736 ↗InjuryJun 6, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT PATIENT FACED INFUSION SET ACCIDENTALLY PULLED OUT EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MDI (MULTIPLE DAILY INJECTIONS).
Patient problems: Hyperglycemia
MAUDE report 25419458 ↗InjuryJun 6, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT PATIENT FACED INFUSION SET ACCIDENTALLY PULLED OUT EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MDI (MULTIPLE DAILY INJECTIONS).
Patient problems: Hyperglycemia
MAUDE report 25419454 ↗InjuryJun 6, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT PATIENT FACED INFUSION SET ACCIDENTALLY PULLED OUT EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MDI (MULTIPLE DAILY INJECTIONS).
Patient problems: Hyperglycemia
MAUDE report 25419451 ↗InjuryJun 6, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT PATIENT FACED INFUSION SET ACCIDENTALLY PULLED OUT EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MDI (MULTIPLE DAILY INJECTIONS).
Patient problems: Hyperglycemia
MAUDE report 25419433 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD HIGH BLOOD GLUCOSE LEVELS AND IT WAS TREATED WITH MULTIPLE DAILY INJECTION (MDI) ON (B)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 24908799 ↗MalfunctionApr 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET FELL OFF DURING USE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797080 ↗MalfunctionApr 7, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET FELL OFF DURING USE ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796998 ↗MalfunctionApr 1, 2026Use of Incorrect Control/Treatment Settings
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WHERE TWO INFUSION SETS WERE ACCIDENTALLY PULLED OUT DURING USE DUE TO TUBING CATCHING ON SOMETHING OR PUMP FALLING ON (B)(6)-2026. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750790 ↗MalfunctionApr 1, 2026Use of Incorrect Control/Treatment Settings
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED ADHESIVE EVENTS WHERE TWO INFUSION SETS WERE ACCIDENTALLY PULLED OUT DURING USE DUE TO TUBING CATCHING ON SOMETHING OR PUMP FALLING ON (B)(6)-2026. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750786 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN LEAKAGE EVENT WITH TWO INFUSION SETS ON (B)(6) 2024. THE INFUSION SET TUBING WAS AT LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE HOUR. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713772 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN LEAKAGE EVENT WITH TWO INFUSION SETS ON (B)(6) 2024. THE INFUSION SET TUBING WAS AT LEAKING AT THE SITE. THE INFUSION SET WAS IN USE FOR ONE HOUR. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713122 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TUBING ISSUE WITH INFUSION SET ON (B)(6) 2023 AS THE INFUSION SET TUBING WAS DETACHED FROM CONNECTOR AS THE T-LOCK WAS FAULTY AND PATIENT FACED THIS EVENT WITH AROUND TWENTY-FIVE INFUSION SETS. THE BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT THE TIME OF EVENT. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712615 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TUBING ISSUE WITH INFUSION SET ON (B)(6) 2023 AS THE INFUSION SET TUBING WAS DETACHED FROM CONNECTOR AS THE T-LOCK WAS FAULTY AND PATIENT FACED THIS EVENT WITH AROUND TWENTY-FIVE INFUSION SETS. THE BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT THE TIME OF EVENT. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712598 ↗InjuryFeb 20, 2026Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS EMDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER QUANTITY. PATIENT WENT TO EMERGENCY ROOM (ER) (B)(6) 2026 DUE TO HYPERGLYCEMIA. PATIENT REPORTED BENT CANNULA AFTER INSERTION EVENT ON 09-FEB-2026. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) FLUIDS OF SALINE AND INSULIN AND PATIENT DID CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. PATIENT RELEASED FROM THE HOSPITAL ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 24398490 ↗InjuryFeb 20, 2026Material Twisted/Bent
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. PATIENT WENT TO EMERGENCY ROOM (ER) (B)(6) 2026 DUE TO HYPERGLYCEMIA. PATIENT REPORTED BENT CANNULA AFTER INSERTION EVENT ON (B)(6) 2026. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) FLUIDS OF SALINE AND INSULIN AND PATIENT DID CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. PATIENT RELEASED FROM THE HOSPITAL ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 24398488 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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