MiniMed™ Mio™ Advance MMT-243ATRecalls & 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 that delivers insulin under the skin. Most of the 62 reports describe the set coming apart too early or the adhesive not holding, sometimes with leaking; a few mention high or low blood sugar. Reports describe 3 injuries and no deaths, with 52 reports in the past 12 months versus 4 in the prior 12 months. 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
- 81
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05705244025172), received between Aug 1, 2022 and Sep 30, 2026 — classified as 13 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (47 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 Bond47
- Premature Separation47
- Leak/Splash8
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available6
- Use of Incorrect Control/Treatment Settings5
- Detachment of Device or Device Component3
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- Hyperglycemia12
- Hypoglycemia3
- Scar Tissue1
- Subcutaneous Nodule1
Recent adverse event reports
The 25 most recent of 81 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 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 50942627 ↗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 50942581 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6) 2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895223 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6)2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895222 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6)2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895221 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6)2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895220 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6)2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895181 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the six infusion sets insulin flow was blocked which led to high glucose level on (b)(6)2026. The insulin was sent through the pump to lower the glucose level.
Patient problems: Hyperglycemia
MAUDE report 50895177 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where leak from the insertion site of infusion set on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869341 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where there was leak from the insertion site of infusion set on (b)(6)2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866817 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where there was leak from the insertion site of infusion set on (b)(6)2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866816 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where infusion set was leaking at the site on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866719 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that the patient infusion set tubing came apart on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850917 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823094 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient face issue of low blood glucose level which was treated by eating graham crackers on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50823092 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50823083 ↗MalfunctionSep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822057 ↗MalfunctionSep 4, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient reported Set fell off due to caught on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611076 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an event of high blood glucose of level 220mg/dl that was treated with insulin pen on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50590421 ↗MalfunctionAug 31, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515487 ↗InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50511203 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499558 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50499540 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494624 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494576 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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