Mio® MMT-943TRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244020559), received between Apr 30, 2019 and Jul 17, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Twisted/Bent1
- Patient Device Interaction Problem1
Patient problems
- Hyperglycemia2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2019Material Twisted/Bent; Patient Device Interaction Problem; Material Twisted/Bent; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 478 AND 570 MG/DL. THE CUSTOMER DID NOT PROVIDE THE SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THAT THE INFUSION SET WAS NOT DELIVERED ENOUGH INSULIN AND THEY FOUND OUT THAT INFUSION SET WAS KINKED. CUSTOMER REPORTED THAT THE PRODUCT NOT ADHERING. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8799410 ↗InjuryApr 30, 2019Break; Break
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD ISSUES WITH THEIR INFUSION SETS. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 474 MG/DL. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON TREATMENT OF THE BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT THEY INSERTED A SET AND WHEN THEY TOOK IT OFF THE SKIN THE CANNULA WAS NOT IN THE BODY. THE CUSTOMER WAS ASSISTED WITH HAVING THEIR INFUSION SETS REPLACED.
Patient problems: Hyperglycemia
MAUDE report 8567075 ↗
Other Set, Administration, Intravascular devices
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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
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- 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.
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