Minimed™ Quick-set™ MMT-397ATRecalls & 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
Quick summary
This Minimed Quick-set MMT-397AT is a single-use infusion set that delivers insulin under the skin. Reports mostly describe the set coming apart too early, the tubing twisting or detaching, and the cannula bending or breaking, which can interrupt insulin delivery and lead to high blood sugar. There are 60 reports, including 2 deaths and 17 injuries, and 39 of them came in the last 12 months compared with 14 in the prior 12 months. No recalls name this device.
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
- 77
- Deaths reported
- 2
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 05705244024908), received between Sep 13, 2023 and Sep 28, 2026 — classified as 2 deaths, 21 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (20 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation20
- Loss of or Failure to Bond19
- Infusion or Flow Problem15
- Material Twisted/Bent9
- Leak/Splash8
- Complete Blockage7
- Adverse Event Without Identified Device or Use Problem5
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- Hyperglycemia22
- Vomiting3
- Elevated Ketones/ Diabetic Ketoacidosis2
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 77 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 patient faced an event of tape not sticking issue on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912273 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event of tape not sticking issue on(b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912264 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly with the set bouncing out during insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912108 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911454 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911285 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907696 ↗InjurySep 25, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient had high blood glucose due to infusion set cannula was bent and treated with pump event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50894078 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the infusion set was accidentally pulled out on (b)(6)2026. The customer reported that the event occurred when the infusion set was unintentionally dislodged, resulting in loss of adhesion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894044 ↗InjurySep 21, 2026Complete Blockage; Leak/Splash; Material Twisted/Bent
It was reported that the patient experienced infusion set failure where the infusion set cannula was bent causing leakage which led to high blood glucose event on (b)(6) 2026 and it was addressed by insulin pump.
Patient problems: Hyperglycemia
MAUDE report 50837452 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834409 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where infusion set fell off due to sweat on (b)(6)026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824172 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824079 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824069 ↗InjurySep 13, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50747112 ↗MalfunctionSep 6, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50638008 ↗MalfunctionSep 6, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50637477 ↗MalfunctionSep 6, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50637386 ↗MalfunctionAug 25, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436872 ↗InjuryAug 24, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient faced an infusion set cannula bent event on (b)(6) 2026 which led to high blood glucose and it was treated with insulin bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50409384 ↗InjuryAug 20, 2026Leak/Splash
It was reported that patient experienced hyperglycemia which was treated with insulin pump due to infusion set leaking at site on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50342635 ↗InjuryAug 20, 2026Fluid/Blood Leak
It was reported that the patient faced an event tubing detached from tubing connector on (b)(6) which led to high blood glucose levels.
Patient problems: Hyperglycemia
MAUDE report 50337262 ↗InjuryAug 18, 2026Device Handling Problem
The patient reported high Blood Glucose on (b)(6) 2026 by using expired infusion set, the blood glucose levels were (326 mg/dL and 373 mg/dL on (b)(6) 2026, 446 mg/dL on 18 Jul 2026) for which syringe was used as a treatment.
Patient problems: Hyperglycemia; Vomiting
MAUDE report 50295427 ↗InjuryAug 18, 2026Device Handling Problem
The patient reported high Blood Glucose on (b)(6) 2026 by using expired infusion set, the blood glucose levels were (326 mg/dL and 373 mg/dL on (b)(6) 2026, 446 mg/dL on (b)(6) 2026) for which syringe was used as a treatment.
Patient problems: Hyperglycemia; Vomiting
MAUDE report 50295423 ↗InjuryAug 18, 2026Device Handling Problem
The patient reported high Blood Glucose on (b)(6) 2026 by using expired infusion set, the blood glucose levels were (326 mg/dL and 373 mg/dL on 17 Jul 2026, 446 mg/dL on (b)(6) 2026) for which syringe was used as a treatment.
Patient problems: Hyperglycemia; Vomiting
MAUDE report 50295421 ↗MalfunctionAug 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50294198 ↗
Other Set, Administration, Intravascular devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.