Sure-T® MMT-875Recalls & 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244006010), received between Jan 21, 2019 and Mar 27, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN COMING OUT OF TUBING AFTER SET CHANGE. THIS ISSUE OCCURRED WITH ONE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8454762 ↗InjuryJan 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE NEEDLE BROKE AND REMAINED IN THE BODY. REPORTEDLY, SURGERY WAS NEEDED TO REMOVE IT. THE PACK OF INFUSION SETS WAS REPLACED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Tissue Damage
MAUDE report 8263603 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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