MiniMed™ Sure T™ MMT866ARecalls & 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 MiniMed Sure-T infusion set is a single-use tube that delivers insulin under the skin. Its 186 reports include 2 deaths and 64 injuries, describing the set detaching, leaking or blocking insulin. Some reports mention high blood sugar and ketones, and one death was reported as due to pneumonia while the set was not worn. Reports in the last 12 months (93) are up from 45 in the prior 12 months, and 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
- 234
- Deaths reported
- 2
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 05705244019324), received between Nov 10, 2020 and Sep 28, 2026 — classified as 2 deaths, 80 injuries, 152 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (40 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
- Adverse Event Without Identified Device or Use Problem56
- Detachment of Device or Device Component40
- Leak/Splash36
- Premature Separation28
- Loss of or Failure to Bond26
- Infusion or Flow Problem20
- Complete Blockage19
- Material Twisted/Bent8
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- Hyperglycemia73
- Elevated Ketones/ Diabetic Ketoacidosis18
- Hypoglycemia14
- Tissue Breakdown3
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Convulsion/Seizure1
Recent adverse event reports
The 25 most recent of 234 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced hyperglycemia, which was managed using pump-delivered insulin, on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50915566 ↗MalfunctionSep 28, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50911482 ↗MalfunctionSep 28, 2026Material Twisted/Bent
It was reported that patient faced tubing was blocked event on (b)(6)2026 and patient experienced high blood glucose level addressed by changing the set.
Patient problems: Hyperglycemia
MAUDE report 50911461 ↗MalfunctionSep 28, 2026Complete Blockage
It was reported that patient faced blocked tube event on (b)(6) 2026 and patient experienced high blood glucose level and changed the infusion set.
Patient problems: Hyperglycemia
MAUDE report 50911459 ↗MalfunctionSep 28, 2026Complete Blockage
It was reported that patient faced tube blocked event on (b)(6)-2026 and patient experiencedhigh blood glucose level and addressed by changing the infusion set.
Patient problems: Hyperglycemia
MAUDE report 50911449 ↗MalfunctionSep 28, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50911448 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910106 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910105 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910104 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910103 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910102 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910101 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910098 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50910096 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910055 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910051 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910047 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910046 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910045 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910013 ↗MalfunctionSep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50909934 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909697 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909622 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908060 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50907305 ↗
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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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