MiniMed™ Sure T™ MMT-864ARecalls & 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
Quick summary
This is a MiniMed Sure-T infusion set for subcutaneous infusion. The 621 reports mostly describe the set failing to stay attached, parts separating, and flow problems, with some patients having high or low blood sugar. There are 193 injuries and no deaths. No recalls name this device. Reports in the last 12 months rose to 390 from 117.
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
- 755
- Deaths reported
- 0
- Injuries reported
- 261
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 755 adverse event reports that list this exact device (DI 05705244019294), received between May 18, 2020 and Sep 30, 2026 — classified as 261 injuries, 494 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (179 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 Bond179
- Adverse Event Without Identified Device or Use Problem174
- Premature Separation168
- Detachment of Device or Device Component94
- Infusion or Flow Problem80
- Use of Incorrect Control/Treatment Settings66
- Leak/Splash43
- Appropriate Device Problem Term/Code Not Available33
Patient problems
- No Clinical Signs, Symptoms or Conditions454
- Hyperglycemia200
- Hypoglycemia51
- Elevated Ketones/ Diabetic Ketoacidosis37
- Hemorrhage/Blood Loss/Bleeding10
- Vomiting4
- Abscess3
- Fatigue3
Recent adverse event reports
The 25 most recent of 755 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event where an Infusion set tape not sticking in the same day of insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950117 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949715 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set tape not sticking as infusion set was pulled off on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944623 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported infusion set fell off during use due to tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942168 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50932621 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50930391 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection
It was reported that patient experienced disconnection difficulty on (b)(6) 2026 due to infusion set quick release was not tightly connected and is not able to connect quick release successfully.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930073 ↗InjurySep 29, 2026Obstruction of Flow; Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50929961 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Confusion/ Disorientation; Fatigue; Hyperglycemia
MAUDE report 50928572 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928565 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927627 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50923475 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hypoglycemia event which was treated with sugar intake on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50915313 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose on (b)(6) 2026 which was treated by insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50913827 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a high blood glucose level, and the issue was treated with a set and reservoir change and a bolus correction on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50912254 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly and fell off led to hyperglycemia event on (b)(6) 2026, which was treated via insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50911975 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6) 2026 which was addressed by insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50911908 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced low blood glucose caused by physical activity event on (b)(6) 2026 which was addressed by carb intake and ate supper.
Patient problems: Hypoglycemia
MAUDE report 50911902 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50909816 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909805 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908186 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hot Flashes/Flushes
MAUDE report 50907061 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced low blood glucose levels 40 mg/dl and treated with eating carb dextrose intake event on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50895836 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia issues on (b)(6) 2026 and was treated by insulin from pump.
Patient problems: Hyperglycemia
MAUDE report 50895536 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hyperglycemia issues on (b)(6) 2026 and was treated by bolus pump manually.
Patient problems: Hyperglycemia
MAUDE report 50895459 ↗
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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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