Sure-TRecalls & reported problems across all models
Unomedical A/S · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 2 models of Sure-T by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2019 and Apr 16, 2026 — classified as 11 injuries, 69 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (29 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
Reports received per month, all models
Most reported Sure-T problems
Device problems
- Premature Separation29
- Loss of or Failure to Bond27
- Use of Incorrect Control/Treatment Settings17
- Material Deformation6
- Partial Blockage5
- Detachment of Device or Device Component4
- Leak/Splash4
- Device Handling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Hyperglycemia21
- Elevated Ketones/ Diabetic Ketoacidosis4
- Confusion/ Disorientation2
- Discomfort2
- Tissue Damage2
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Sure-T models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sure-T® MMT-863Set, Administration, Intravascular78 reports
- Sure-T® MMT-875Set, Administration, Intravascular2 reports
Recent Sure-T adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, PATIENT STATED SITE AREA SEEMS TO BE WET FROM INSULIN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903013 ↗MalfunctionApr 16, 2026Loss of or Failure to Bond
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, PATIENT REPORTED INFUSION SET TUBING GOT CAUGHT AND PULLED. THE PATIENT ALSO REPORTED AFTER PULLING THE SITE IT WAS HURTING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24902978 ↗MalfunctionApr 12, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET WAS NOT ADHERING PROPERLY TO THE SKIN ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853160 ↗MalfunctionApr 11, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE INFUSION SET ADHESIVE WAS NOT STICKING PROPERLY TO THE BODY ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24849874 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ACCIDENTALLY RIPS EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833069 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ACCIDENTALLY RIPS EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831225 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ACCIDENTALLY RIPS EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831224 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ACCIDENTALLY RIPS EVENT ON 18-FEB-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831223 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ACCIDENTALLY RIPS EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827574 ↗MalfunctionApr 9, 2026Premature Separation
THE PATIENT REPORTED THE INFUSION SET DETACHED DURING SLEEP ON (B)(6) 2024, RESULTING IN BLOOD GLUCOSE ELEVATION TO 270 MG/DL SUSTAINED FOR 5 HOURS, WHICH FURTHER INCREASED TO 352 MG/DL FOLLOWING A MEAL DESPITE CHANGING THE INFUSION SITE.
Patient problems: Hyperglycemia
MAUDE report 24826404 ↗MalfunctionApr 9, 2026Premature Separation
THE PATIENT REPORTED THAT THE INFUSION SET REPEATEDLY DETACHED WHILE AT SHOWER ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24826049 ↗MalfunctionApr 9, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT UNINTENTIONALLY PULLED OUT THEIR INFUSION SET ON 10-MAY-2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825512 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET ACCIDENTALLY CAME OFF ON (B)(6) 2025. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824387 ↗MalfunctionApr 8, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT DID NOT HAVE THE STICKY ADHESIVE WHEN THEY REMOVED THE PAPER BACKING EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824346 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET ACCIDENTALLY RIPPED OUT OF THE BODY ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824312 ↗
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
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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