Minimed MioRecalls & reported problems across all models
Unomedical A/S · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 360
- Deaths reported
- 2
- Injuries reported
- 118
- Recalls
- 0
We found 14 models of Minimed Mio by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 360 adverse event reports in the FDA's MAUDE database, received between Jun 25, 2020 and Sep 18, 2026 — classified as 2 deaths, 118 injuries, 240 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (89 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 Mio problems
Device problems
- Material Twisted/Bent89
- Detachment of Device or Device Component64
- Leak/Splash59
- Infusion or Flow Problem50
- Loss of or Failure to Bond34
- Adverse Event Without Identified Device or Use Problem23
- No Apparent Adverse Event12
- Premature Separation9
Patient problems
- No Clinical Signs, Symptoms or Conditions182
- Elevated Ketones/ Diabetic Ketoacidosis86
- Hyperglycemia83
- Hypoglycemia6
- Vomiting4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Headache3
- Fatigue2
Minimed Mio models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Minimed™ Mio™ MMT-943ASet, Administration, Intravascular1 death108 reports
- Minimed™ Mio™ MMT-975ASet, Administration, Intravascular80 reports
- Minimed™ Mio™ MMT-923ASet, Administration, Intravascular1 death40 reports
- Minimed™ Mio™ MMT-941A600Set, Administration, Intravascular30 reports
- Minimed™ Mio™ MMT-943A600Set, Administration, Intravascular20 reports
- Minimed™ Mio™ MMT-921ASet, Administration, Intravascular19 reports
- Minimed™ Mio™ MMT-965A600Set, Administration, Intravascular13 reports
- Minimed™ Mio™ MMT-941ASet, Administration, Intravascular10 reports
- Minimed™ Mio™ MMT-925ASet, Administration, Intravascular9 reports
- Minimed™ Mio™ MMT-975A600Set, Administration, Intravascular8 reports
- Minimed™ Mio™ MMT-923A600Set, Administration, Intravascular7 reports
- Minimed™ Mio™ MMT-945A600Set, Administration, Intravascular6 reports
- Minimed™ Mio™ MMT-965ASet, Administration, Intravascular5 reports
- Minimed™ Mio™ MMT-921A600Set, Administration, Intravascular5 reports
Recent Minimed Mio adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of or Failure to Bond; Leak/Splash; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50821080 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50628828 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was hospitalized due to elevated blood glucose levels of 200 mg/dl and elevated ketone levels event on (b)(6) 2026 and was treated with intravenous insulin.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50537901 ↗MalfunctionAug 31, 2026Device Handling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518034 ↗InjuryAug 31, 2026Leak/Splash
It was reported that the patient experienced leakage from the site which led to high blood glucose addressed by insulin pen, on (b)(6)2024.
Patient problems: Hyperglycemia
MAUDE report 50515318 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512210 ↗MalfunctionAug 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50451538 ↗InjuryAug 25, 2026Leak/Splash
Patient reported infusion set was leaking at site led to high blood glucose event and was treated with pump event occurred on(b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50430810 ↗InjuryAug 21, 2026Leak/Splash
It was reported that patient faced an infusion set leak at site events on (b)(6) 2024 which led to high blood glucose and it was treated with insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50370603 ↗InjuryAug 18, 2026Fluid/Blood Leak
It was reported that patient experienced high blood glucose and treated with pen on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50294861 ↗InjuryAug 18, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing was leaking at site of insertion on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50294189 ↗InjuryAug 11, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50207037 ↗InjuryAug 8, 2026Fluid/Blood Leak
It was reported that the patient's infusion set was leaking at the site that lead to hyperglycemia event which was treated with insulin pump on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50187253 ↗InjuryAug 8, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50185073 ↗InjuryAug 6, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50156427 ↗
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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