MiniMed™ Sure T™ MMT-884ARecalls & 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 MiniMed Infusion Sets (58) · MiniMed Sure T (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05705244019416), received between Nov 20, 2024 and Aug 16, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond4
- Premature Separation4
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Tissue Breakdown2
- Hyperglycemia1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266483 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266179 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking due to hot weather event on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264642 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking due to hot weather event on 17 Jul 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264310 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4) EVENT OCCURED IN GERMANY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIA EVENT ON (B)(6) 2026, WITH LEVELS REMAINING ELEVATED FOR TWO HOURS AND THE PATIENT GOT TREATED WITH INSULIN PUMP. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 24680266 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Tissue Breakdown
MAUDE report 23703192 ↗MalfunctionNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Tissue Breakdown
MAUDE report 23601416 ↗MalfunctionNov 20, 2024Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT HAD INSULIN FLOW BLOCKED OCCURRED ON (B)(6) 2024. THE PUMP DETECTED AN OCCLUSION THAT PREVENTS THE FLOW OF INSULIN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20741921 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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