Minimed™ Quick-set™ MMT-399A (UDI 05705244017467)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 Quick-set (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244017467), received between May 25, 2024 and Sep 28, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
- Complete Blockage3
- Loss of or Failure to Bond3
- Premature Separation3
Patient problems
- Hyperglycemia4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the tape not sticking due to perspiration/weather event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912268 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911879 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911877 ↗InjuryAug 9, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced infusion set cannula was bent event on (b)(6) 2026. Due to the event, patient has high blood glucose level and was treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50188637 ↗InjuryAug 8, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced infusion set cannula was bent event on (b)(6) 2026. Due to the event, patient has high blood glucose levels and was Corrected with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50185662 ↗InjuryAug 8, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced infusion set cannula was bent event on (b)(6) 2026. Due to the event, patient has high blood glucose level and was treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50185648 ↗MalfunctionMay 25, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENT ON 22-APR-2024.THE INFUSION SET WAS IN USE FOR ONE DAY. THE INSERTION SITE WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 417 MG/DL AT THE TIME OF EVENT AND THE PATIENT WAS TREATED WITH EMERGENCY KIT AND CHANGE THE INFUSION SET. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 19398182 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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