MiniMed™ Mio™ Advance MMT-242 (UDI 05705244016323)Recalls & 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 is a MiniMed Mio Advance MMT-242 infusion set, a single-use insulin delivery set placed under the skin. Most of the 46 reports describe the set coming loose or apart — the cannula or tape detaching, the site separating early, or leaks. Ten people were injured and one death was reported; several reports mention high blood sugar and diabetic ketoacidosis after insulin delivery was interrupted. No recalls name this device. Reports rose from 8 in the previous 12 months to 19 in the most recent 12 months.
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
- 50
- Deaths reported
- 1
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 05705244016323), received between Jun 2, 2020 and Sep 30, 2026 — classified as 1 death, 10 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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
- Detachment of Device or Device Component19
- Adverse Event Without Identified Device or Use Problem12
- Premature Separation11
- Loss of or Failure to Bond9
- Leak/Splash4
- Use of Incorrect Control/Treatment Settings4
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Hyperglycemia10
- Elevated Ketones/ Diabetic Ketoacidosis4
- No Known Impact Or Consequence To Patient2
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 50 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 50950650 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907528 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906791 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where tape was not sticking due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896276 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced hyperglycemia event which was treated with corrective bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50445893 ↗MalfunctionAug 16, 2026Premature Separation
It was reported that patient faced issue with tape not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266446 ↗MalfunctionAug 14, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced an infusion set cannula fell off due to sports activity and sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250567 ↗MalfunctionAug 14, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250566 ↗MalfunctionAug 14, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250537 ↗MalfunctionAug 14, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced an infusion set cannula fell off due to sports activity and sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250531 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247105 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247096 ↗MalfunctionAug 6, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50152137 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an infusion set tape did not stick due to sweat event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151066 ↗DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481857 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE EVENT WHICH WAS MANAGED WITH INSULIN DELIVERY ON (B)(6) 2026. THE EVENT LASTED LESS THAN ONE HOUR.
Patient problems: Hyperglycemia
MAUDE report 24962867 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE EVENT WHICH WAS MANAGED WITH INSULIN DELIVERY ON (B)(6) 2026. THE EVENT LASTED LESS THAN ONE HOUR.
Patient problems: Hyperglycemia
MAUDE report 24961998 ↗MalfunctionApr 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE WAS NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949309 ↗MalfunctionApr 21, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT PATIENT FACED ISSUE WITH INFUSION SET ON (B)(6) 2026 AS THE TAPE DID NOT STICK TO THE SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935670 ↗InjuryApr 17, 2026Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT ON (B)(6) 2026, WHERE INFUSION SET HAD COME OUT OF PATIENT'S BODY WHEN THE PATIENT WOKE UP. THE PATIENT WAS HOSPITALIZED.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 24918897 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIC EVENT ON 02 MAR 2026 AND WAS TREATED WITH INSULIN VIA INJECTION AND PUMP THERAPY. THE BLOOD GLUCOSE WAS HIGH FOR ONE TO TWO HOURS.
Patient problems: Hyperglycemia
MAUDE report 24751760 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026. THE HIGH BLOOD GLUCOSE EVENT LASTED GREATER THAN FOUR HOURS. THE PATIENT RECEIVED TREATMENT WITH INSULIN VIA PUMP, AND THE EVENT RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 24659849 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURED IN SPAIN. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT OCCURRED CLOSE TO THE SITE LOCATION. THE INFUSION SET WAS IN USE FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578984 ↗MalfunctionAug 11, 2025Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22768700 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 415 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN INJECTION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 22528077 ↗
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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