Medtronic ExtendedRecalls & reported problems across all models
Unomedical A/S · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22,785
- Deaths reported
- 34
- Injuries reported
- 4,148
- Recalls
- 0
We found 27 models of Medtronic Extended by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 22,785 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2022 and Sep 30, 2026 — classified as 34 deaths, 4,148 injuries, 18,601 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (11,365 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Medtronic Extended problems
Device problems
- Loss of or Failure to Bond11,365
- Premature Separation11,134
- Adverse Event Without Identified Device or Use Problem2,986
- Leak/Splash2,186
- Use of Incorrect Control/Treatment Settings2,003
- Fluid/Blood Leak925
- Detachment of Device or Device Component891
- Infusion or Flow Problem510
Patient problems
- No Clinical Signs, Symptoms or Conditions17,452
- Hyperglycemia3,857
- Hypoglycemia667
- Elevated Ketones/ Diabetic Ketoacidosis321
- Skin Inflammation/ Irritation175
- Hemorrhage/Blood Loss/Bleeding141
- Pain106
- Skin Infection77
Medtronic Extended models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Medtronic Extended MMT-431ASet, Administration, Intravascular3 deaths8,574 reports
- Medtronic Extended MMT-431AGSet, Administration, Intravascular14 deaths3,397 reports
- Medtronic Extended MMT-441AGSet, Administration, Intravascular7 deaths2,000 reports
- Medtronic Extended MMT-431AJSet, Administration, Intravascular1 death1,659 reports
- Medtronic Extended MMT-431AKSet, Administration, Intravascular1 death1,206 reports
- Medtronic Extended MMT-441ASet, Administration, Intravascular1 death1,162 reports
- Medtronic Extended MMT-442AGSet, Administration, Intravascular2 deaths1,073 reports
- Medtronic Extended MMT-441AKSet, Administration, Intravascular545 reports
- Medtronic Extended MMT-442ASet, Administration, Intravascular1 death536 reports
- Medtronic Extended MMT-432ASet, Administration, Intravascular2 deaths487 reports
- Medtronic Extended MMT-441AJSet, Administration, Intravascular1 death449 reports
- Medtronic Extended MMT-432AGSet, Administration, Intravascular1 death356 reports
- Medtronic Extended MMT-442AJSet, Administration, Intravascular299 reports
- Medtronic Extended MMT-442AKSet, Administration, Intravascular259 reports
- Medtronic Extended MMT-431AHSet, Administration, Intravascular174 reports
- Medtronic Extended MMT-432AKSet, Administration, Intravascular162 reports
- Medtronic Extended MMT-443AGSet, Administration, Intravascular105 reports
- Medtronic Extended MMT-432AJSet, Administration, Intravascular79 reports
- Medtronic Extended MMT-442AHSet, Administration, Intravascular75 reports
- Medtronic Extended MMT-441AHSet, Administration, Intravascular72 reports
- Medtronic Extended MMT-433AGSet, Administration, Intravascular38 reports
- Medtronic Extended MMT-443AJSet, Administration, Intravascular32 reports
- Medtronic Extended MMT-443AKSet, Administration, Intravascular21 reports
- Medtronic Extended MMT-433AKSet, Administration, Intravascular12 reports
- Medtronic Extended MMT-433AJSet, Administration, Intravascular8 reports
- Medtronic Extended MMT-432AHSet, Administration, Intravascular4 reports
- Medtronic Extended MMT-443ASet, Administration, Intravascular1 report
Recent Medtronic Extended adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951930 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951646 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951644 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951630 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951566 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951564 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951563 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set tape started peeling off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951559 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951558 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951553 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951552 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to the patient went into the water on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951551 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951547 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951545 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951541 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- MiniMed Infusion Sets58 models · 30,240 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
- inset13 models · 2,869 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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