Sure-T® MMT-863Recalls & 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
All models of Sure-T (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical Sure-T infusion set is a single-use tube set for infusing medicine under the skin. Of its 78 reports, 68 are malfunctions and 10 are injuries, with no deaths. Many describe the set coming off early or not sticking, and some report high blood sugar. Reports rose to 70 in the last 12 months from 6 in the prior 12 months. 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
- 78
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 05705244005693), received between Feb 15, 2019 and Apr 16, 2026 — classified as 10 injuries, 68 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation29
- Loss of or Failure to Bond27
- Use of Incorrect Control/Treatment Settings17
- Material Deformation6
- Partial Blockage5
- Leak/Splash4
- Detachment of Device or Device Component2
- Device Handling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Hyperglycemia21
- Elevated Ketones/ Diabetic Ketoacidosis4
- Confusion/ Disorientation2
- Discomfort2
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 78 reports, 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 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET CAME OFF WHILE SLEEPING DUE TO TOSSING AND TURNING ON (B)(6) 2024. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824247 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET ACCIDENTALLY CAUGHT ON THE DRAWER HANDLE AND RIPPED OFF OF THE SKIN ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824224 ↗MalfunctionApr 8, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ADHESIVE AND NEEDLE HAD COME OFF OF THEM EVENT ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE EVENT.
Patient problems: Hyperglycemia
MAUDE report 24824178 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET ACCIDENTALLY PULLED OFF WHILE CHANGING CLOTHES ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824155 ↗MalfunctionApr 8, 2026Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET FELL OFF EVENT ON (B)(6) 2025 WHILE PATIENT DID A SUPPLY CHANGE EARLIER AND ADHESIVE CAME LOOSE AND INFUSION SET COMPLETELY CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818021 ↗MalfunctionApr 8, 2026Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2024 WHERE SITE CAME OUT WHILE THE PATIENT WAS SLEEPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816969 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET WAS ACCIDENTALLY PULLED OFF WHICH LED TO HYPERGLYCEMIA ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 350 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 24816231 ↗MalfunctionApr 8, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET ADHESIVE WAS NOT STICKING EVENT ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816122 ↗InjuryApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT INFUSION SET WAS ACCIDENTALLY PULLED OUT IN BATHROOM WHICH LED TO HYPERGLYCEMIA ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 267 MG/DL, AND THE PATIENT WAS TREATED WITH MANUAL INJECTION.
Patient problems: Hyperglycemia
MAUDE report 24816116 ↗MalfunctionApr 8, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2025, WHERE PATIENT ACCIDENTALLY FOLDED OVER ADHESIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816011 ↗
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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 14, 2026 · each report above links to its original FDA record
- 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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