MiniMed™ Mio™ Advance MMT-243ARecalls & 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 delivers medication under the skin. Of its 1,117 reports, 3 describe a patient death, 322 describe injuries and 792 describe malfunctions. Many reports describe the adhesive failing to stick, the set coming loose early, and leaks. Some describe high or low blood sugar, and bent cannulas. Reports rose to 806 in the last 12 months from 158 in the previous 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
- 1,563
- Deaths reported
- 3
- Injuries reported
- 474
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,563 adverse event reports that list this exact device (DI 05705244018907), received between Sep 15, 2021 and Sep 30, 2026 — classified as 3 deaths, 474 injuries, 1,086 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (550 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 Bond550
- Premature Separation529
- Adverse Event Without Identified Device or Use Problem333
- Leak/Splash186
- Detachment of Device or Device Component105
- Use of Incorrect Control/Treatment Settings95
- Fluid/Blood Leak66
- Material Twisted/Bent57
Patient problems
- No Clinical Signs, Symptoms or Conditions987
- Hyperglycemia427
- Hypoglycemia75
- Elevated Ketones/ Diabetic Ketoacidosis49
- Hemorrhage/Blood Loss/Bleeding22
- Pain7
- Fatigue3
- Headache3
Recent adverse event reports
The 25 most recent of 1,563 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949955 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949954 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on (b)(6) 2026 in which infusion set was falling off due to sweat.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949947 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set cannula off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949416 ↗InjurySep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50946372 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an infusion set adhesive failure on (b)(6) 2026, where the tape not sticking due to sweat while showering.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944077 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient had high blood glucose (312 MG/DL) and treated with Insulin Pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50944059 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set was pulled off after it got caught on the patient's clothes on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943754 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set tubing may get pulled or the infusion site may get bumped frequently during use, contributing to the reported infusion set issue on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943741 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and high blood glucose of 300 mg/dL. The high blood glucose persisted for 1 to 2 hours and was treated using the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50942969 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that patient faced an event of infusion set tubing completely detached from tubing connector after one day of use on (b)(6) 2026. Insertion site was right abdomen.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942827 ↗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 after swimming and coming loose on the first day of use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942625 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942274 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported infusion set fell off during use due to swimming on 19 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942178 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported infusion set fell during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942154 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hypoglycemia event on (b)(6) 2026 which was corrected with orange.
Patient problems: Hypoglycemia
MAUDE report 50942033 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935785 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935201 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event with infusion set where infusion set tape not sticking due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931233 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931228 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929554 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929540 ↗InjurySep 29, 2026Material Twisted/Bent
It was reported that the patient experienced high blood glucose (391 mg/dL) on (b)(6) 2026 due to a bent cannula at an abdominal insertion site. The event was treated using the insulin pump, The bent cannula was identified after 2 days of use.
Patient problems: Hyperglycemia
MAUDE report 50929115 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50928927 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50928618 ↗
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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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