Mio® MMT-975TRecalls & 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 Mio (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244020580), received between Jun 6, 2019 and Aug 10, 2020 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak3
- Detachment of Device or Device Component1
Patient problems
- Hyperglycemia3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 441 MG/DL. CUSTOMER STATED THAT INSULIN PUMP HAD LEAK AT SITE AND WAS NOT ABLE TO CHANGE THE INFUSION SET. CUSTOMER STATED THAT THEY TREATED WITH INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INFUSION SET WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10383884 ↗MalfunctionJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD INSULIN LEAK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WILL BE SENT A NEW INFUSION SET TWP PACK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8713406 ↗MalfunctionJun 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY HAD AN OCCLUSION WITH THEIR INFUSION SET CAUSING AN INSULIN LEAK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 243 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT TROUBLESHOOT AND DID NOT SEND THE PRODUCT BACK FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8689448 ↗InjuryJun 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY HAD AN OCCLUSION WITH THEIR INFUSION SET. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 464 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY TRIED MULTIPLE SETS BUT HAD ALL FAILED. THE CUSTOMER STATES THAT THE INFUSION SETS ARE NOT LASTING THE FULL TIME FRAME IN WHICH THEY SHOULD LAST. THE CUSTOMER REVERTED TO THEIR BACK UP PLAN BUT DID NOT STATE HOW THEY TREATED THEIR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT TROUBLESHOOT BUT DID SEND THE PRODUCT BACK FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8675209 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page