MiniMed™ Mio™ Advance MMT-242TRecalls & 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
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05705244016507), received between Mar 20, 2026 and Apr 10, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (6 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
- Premature Separation6
- Loss of or Failure to Bond5
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Premature Separation
IT WAS REPORTED THAT INFUSION SET TAPE NOT STICKING DUE TO SWEATING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838179 ↗MalfunctionMar 24, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE FAILURE ON (B)(6) 2026, AS THE INFUSION SET TAPE DID NOT STICK DUE TO SWEATING, CAUSING THE INFUSION SET TO COME OFF PREMATURELY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679141 ↗MalfunctionMar 23, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN ITALY IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TAPE NOT STICKING ISSUE DURING SHOWER ON (B)(6) 2026. THE INFUSION SET WAS REPORTED TO HAVE COME OFF PREMATURELY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659054 ↗MalfunctionMar 20, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. THE PATIENT REPORTED THAT THE TAPE WAS NOT STICKING ON (B)(6) 2026, AND INFUTION SET FELL OFF WITHOUT ANY ACTIVITY. THE INFUSION SET HAD BEEN IN USE FOR TEN MINUTES. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646854 ↗MalfunctionMar 20, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. THE PATIENT REPORTED THAT THE TAPE WAS NOT STICKING ON (B)(6) 2026, AND INFUTION SET FELL OFF WITHOUT ANY ACTIVITY. THE INFUSION SET HAD BEEN IN USE FOR TEN MINUTES. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646842 ↗MalfunctionMar 20, 2026Loss of or Failure to Bond; Premature Separation
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET ADHESIVE ISSUE EVENT ON (B)(6) 2026. THE INFUSION SET TAPE DID NOT ADHERE AND FELL OFF. THE INFUSION SET WAS IN USE FOR 10 MINUTES. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646819 ↗
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- 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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