Medtronic Extended MMT-432AKRecalls & 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
Quick summary
This Medtronic Extended infusion set is a single-use tube set for subcutaneous insulin infusion. Its 99 adverse event reports include no deaths, 28 injuries and 71 malfunctions. The reports mostly describe the set separating early or failing to bond, leaks at the site, and high blood sugar. Reports in the last 12 months number 77, up from 18 in the year before. 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
- 162
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 05705244025387), received between Oct 8, 2024 and Sep 30, 2026 — classified as 49 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (64 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
- Premature Separation64
- Loss of or Failure to Bond60
- Adverse Event Without Identified Device or Use Problem32
- Leak/Splash25
- Use of Incorrect Control/Treatment Settings9
- Fluid/Blood Leak7
- Infusion or Flow Problem7
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions96
- Hyperglycemia40
- Hypoglycemia8
- Elevated Ketones/ Diabetic Ketoacidosis7
- Pain7
- Erythema6
- Hemorrhage/Blood Loss/Bleeding3
- Vomiting3
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the infusion set leaked at the site on (b)(6)-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942431 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the infusion set leaked at the site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942372 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the infusion set leaked at the site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942370 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the infusion set leaked at the site on (b)(6)-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942369 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was hospitalized due to hypoglycemia event on (b)(6) 2026 and was treated with Intravenous Insulin drip.
Patient problems: Hypoglycemia
MAUDE report 50928561 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927797 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909531 ↗MalfunctionSep 26, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907947 ↗InjurySep 21, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced an infusion set insulin flow blocked event that led to high blood glucose and was treated via manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50840463 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an low blood glucose level event on (b)(6) 2026 which was managed by eating grapes.
Patient problems: Hypoglycemia
MAUDE report 50837806 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50826489 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50824474 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823702 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823693 ↗MalfunctionSep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823692 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823688 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose levels and was treated with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50823600 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822918 ↗InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50822884 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50821827 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821623 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821621 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821609 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821605 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821100 ↗
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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.
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