MiniMed™ Mio™ Advance MMT-244ARecalls & 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 Advance (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MiniMed Mio Advance infusion set, used to deliver insulin under the skin, has 295 reports, including 56 injuries and 1 death. Many describe parts separating, detaching, or leaking, and patients mention high and low blood sugar. Reports rose to 163 in the latest 12 months from 75 in the 12 months before. 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
- 391
- Deaths reported
- 1
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 05705244018938), received between Dec 23, 2021 and Sep 30, 2026 — classified as 1 death, 88 injuries, 302 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (94 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
- Loss of or Failure to Bond94
- Premature Separation89
- Leak/Splash64
- Adverse Event Without Identified Device or Use Problem57
- Detachment of Device or Device Component46
- Use of Incorrect Control/Treatment Settings31
- Fluid/Blood Leak20
- Infusion or Flow Problem19
Patient problems
- No Clinical Signs, Symptoms or Conditions276
- Hyperglycemia68
- Hypoglycemia21
- Hemorrhage/Blood Loss/Bleeding15
- Elevated Ketones/ Diabetic Ketoacidosis10
- Fatigue2
- Convulsion/Seizure1
- Itching Sensation1
Recent adverse event reports
The 25 most recent of 391 reports, in the reporter's own words as published by the FDA.
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 50948362 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50947954 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to sweating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944447 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive issue, with the infusion set tape not sticking due to excessive sweating on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942616 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive issue, with the infusion set tape not sticking due to excessive sweating on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942578 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a high glucose level of 396 mg/dL on (b)(6)2026, approximately more than four hours after the infusion set had been placed on the thigh on first day. The patient was treated with the pen.
Patient problems: Hyperglycemia
MAUDE report 50929105 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50928582 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to hot weather.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912970 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to hot weather.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912961 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on(b)(6) 2026 where the infusion set tape was not sticking due to hot weather.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912959 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the tape not sticking during sleeping event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911874 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911507 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50910216 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50910180 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50910177 ↗MalfunctionSep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909904 ↗MalfunctionSep 27, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909844 ↗MalfunctionSep 26, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907967 ↗MalfunctionSep 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907574 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907299 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50907281 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50906827 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set fell off during normal work on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894201 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion came off due to humidity on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894200 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported by the patient that infusion set came off due to coiled on the door on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894114 ↗
Other Set, Administration, Intravascular devices
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- 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.
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