Minimed™ Mio™ MMT-925ARecalls & 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 Mio (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05705244019959), received between May 20, 2024 and Mar 26, 2026 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash8
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Elevated Ketones/ Diabetic Ketoacidosis2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Leak/Splash
REFRENCE NUMBER (B)(4) EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701611 ↗MalfunctionMar 26, 2026Leak/Splash
REFRENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701548 ↗MalfunctionMar 26, 2026Leak/Splash
REFRENCE NUMBER (B)(4) EVENT OCCURRED IN AUSTRALIA IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701541 ↗MalfunctionMar 26, 2026Leak/Splash
REFRENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701538 ↗MalfunctionMar 26, 2026Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701535 ↗InjurySep 16, 2024No Apparent Adverse Event; No Apparent Adverse Event
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 31-JUL-2024, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE DIABETIC KETOACIDOSIS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 20222184 ↗MalfunctionJun 26, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSIONS SET LEAKAGE EVENT ON (B)(6) 2024 AFTER 24 HOURS. LEAK BEFORE END OF 3 DAYS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19621052 ↗InjuryJun 9, 2024Leak/Splash; No Apparent Adverse Event; Leak/Splash; No Apparent Adverse Event
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED BY THE PATIENT HAD HIGH BLOOD GLUCOSE 497 MG/DL WHEN ADMITTED TO HOSPITAL ON (B)(6) 2024 FROM 9:30 AM TO 3PM. WHEN THE PATIENT WAS ADMITTED TO THE HOSPITAL, SYMPTOMS WERE FEELING SICK/UNWELL AND REASON OF HOSPITALIZATION WAS DIABETIC KETOACIDOSIS. THE PATIENT TREATED WITH IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION) AND REQUESTED A NORMAL PUMP. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 19495201 ↗MalfunctionMay 20, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAK EVENT ON 19-APR-2024. THE LEAK WAS AT SIDE OF THE ATTACHMENT TO THE BODY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349354 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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