MiniMed Sure TRecalls & reported problems across all models
Unomedical A/S · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,318
- Deaths reported
- 2
- Injuries reported
- 453
- Recalls
- 0
We found 7 models of MiniMed Sure T by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 1,318 adverse event reports in the FDA's MAUDE database, received between Jan 29, 2020 and Sep 30, 2026 — classified as 2 deaths, 453 injuries, 863 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (282 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MiniMed Sure T problems
Device problems
- Adverse Event Without Identified Device or Use Problem307
- Loss of or Failure to Bond282
- Premature Separation252
- Detachment of Device or Device Component183
- Infusion or Flow Problem147
- Leak/Splash100
- Use of Incorrect Control/Treatment Settings69
- Appropriate Device Problem Term/Code Not Available56
Patient problems
- No Clinical Signs, Symptoms or Conditions775
- Hyperglycemia354
- Hypoglycemia92
- Elevated Ketones/ Diabetic Ketoacidosis74
- Hemorrhage/Blood Loss/Bleeding13
- Tissue Breakdown9
- Abscess4
- Vomiting4
MiniMed Sure T models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniMed™ Sure T™ MMT-864ASet, Administration, Intravascular755 reports
- MiniMed™ Sure T™ MMT866ASet, Administration, Intravascular2 deaths234 reports
- MiniMed™ Sure T™ MMT-874ASet, Administration, Intravascular133 reports
- MiniMed™ Sure T™ MMT-876ASet, Administration, Intravascular85 reports
- MiniMed™ Sure T™ MMT-862ASet, Administration, Intravascular72 reports
- MiniMed™ Sure T™ MMT-886ASet, Administration, Intravascular31 reports
- MiniMed™ Sure T™ MMT-884ASet, Administration, Intravascular8 reports
Recent MiniMed Sure T adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951641 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950459 ↗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, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948216 ↗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 that patient face issue with tape not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943227 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient face issue with tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943095 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942816 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942813 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942642 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to swimming on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942639 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942610 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942608 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to sweating working caused tape to fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942607 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- MiniMed Infusion Sets58 models · 30,240 reports
- Medtronic Extended27 models · 22,785 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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