Medtronic Extended MMT-433AKRecalls & 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 Medtronic Extended (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05705244025417), received between Aug 3, 2026 and Sep 18, 2026 — classified as 6 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond6
- Premature Separation6
- Adverse Event Without Identified Device or Use Problem5
- Complete Blockage1
- Material Twisted/Bent1
Patient problems
- Hyperglycemia7
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822658 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50822645 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821698 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50821694 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821690 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6)2026 and it was treated with shots.
Patient problems: Hyperglycemia
MAUDE report 50492359 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6)2026 and treated it with bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50466454 ↗MalfunctionAug 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50423890 ↗MalfunctionAug 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411463 ↗InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an elevated blood glucose and was treated with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50265368 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced high blood glucose levels of 222 mg/dl on (b)(6) 2026 and treated with bolus correction.
Patient problems: Hyperglycemia
MAUDE report 50231550 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110003 ↗
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 18, 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