MiniMed™ Mio™ Advance MMT-242ATRecalls & 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 is a single use set for subcutaneous infusion. It has 198 adverse event reports, with no deaths, 16 injuries and 182 malfunctions. Many describe the set coming apart or failing to stay attached, and some mention high blood glucose from leaks. Reports rose sharply, with 167 in the last 12 months compared with 14 the year 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
- 298
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 298 adverse event reports that list this exact device (DI 05705244019058), received between Oct 11, 2022 and Sep 30, 2026 — classified as 29 injuries, 269 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (204 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 Bond204
- Premature Separation203
- Use of Incorrect Control/Treatment Settings21
- Adverse Event Without Identified Device or Use Problem18
- Leak/Splash15
- Detachment of Device or Device Component13
- Fluid/Blood Leak7
- Infusion or Flow Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions259
- Hyperglycemia33
- Elevated Ketones/ Diabetic Ketoacidosis2
- Hypoglycemia2
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 25 most recent of 298 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 the tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951640 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944089 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944071 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944065 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943496 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly due to water on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943482 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape not sticking event due to sweat event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941906 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931217 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced infusion set tape not sticking due to sweat event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912267 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced adhesive issues on (b)(6)2026 as infusion set came off due to tape not sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911681 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set tape not sticking due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911220 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909762 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908283 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908238 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908043 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908013 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907998 ↗MalfunctionSep 26, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907963 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907728 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907680 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907104 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907103 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907102 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907058 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907036 ↗
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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