MiniMed™ Sure T™ MMT-876ARecalls & 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 SureT MMT-876A single-use infusion set, placed under the skin to deliver insulin. Most reports describe the set coming loose or pulling out, along with parts detaching or bonding failing, and leaking. There are 65 reports, including 17 injuries and no deaths, with several mentioning high blood sugar or ketones after insulin delivery was interrupted. There are no recalls naming 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
- 85
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 05705244019386), received between Aug 31, 2021 and Sep 27, 2026 — classified as 35 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (19 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 Problem19
- Infusion or Flow Problem19
- Detachment of Device or Device Component11
- Loss of or Failure to Bond11
- Appropriate Device Problem Term/Code Not Available9
- Leak/Splash8
- Premature Separation8
- Material Deformation3
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Hyperglycemia29
- Elevated Ketones/ Diabetic Ketoacidosis6
- Hypoglycemia5
- Nausea2
- Tissue Breakdown1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50909657 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50823806 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50823789 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50823749 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822314 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822284 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50822279 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822262 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822259 ↗InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced high blood glucose which was addressed by insulin pump delivery event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785242 ↗InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced high blood glucose which was addressed by insulin pump delivery event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785239 ↗InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced high blood glucose which was addressed by insulin pump delivery event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785234 ↗InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced high blood glucose which was addressed by insulin pump delivery event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785230 ↗InjurySep 16, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced high blood glucose which was addressed by insulin pump delivery event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50785229 ↗MalfunctionSep 8, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667387 ↗MalfunctionSep 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50630417 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50629441 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50629440 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50629438 ↗InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50629437 ↗InjuryAug 14, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced infusion set was pulled out event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50250527 ↗MalfunctionAug 12, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the infusion set keeps falling off due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223187 ↗MalfunctionAug 12, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217861 ↗MalfunctionAug 11, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207033 ↗MalfunctionAug 10, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50191560 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page