Medtronic Extended MMT-442AKRecalls & 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 set for subcutaneous infusion. It has 199 adverse event reports, with no deaths, 60 injuries and 139 malfunctions. Many describe the set coming off, leaking or separating, and others mention high or low blood sugar. Reports rose to 150 in the last 12 months from 42 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
- 259
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 05705244025509), received between Sep 13, 2024 and Sep 30, 2026 — classified as 76 injuries, 183 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (84 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 Separation84
- Loss of or Failure to Bond82
- Adverse Event Without Identified Device or Use Problem49
- Leak/Splash48
- Use of Incorrect Control/Treatment Settings22
- Infusion or Flow Problem14
- Fluid/Blood Leak11
- Material Deformation9
Patient problems
- No Clinical Signs, Symptoms or Conditions173
- Hyperglycemia66
- Hypoglycemia11
- Elevated Ketones/ Diabetic Ketoacidosis3
- Localized Skin Lesion2
- Skin Infection2
- Skin Inflammation/ Irritation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 259 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the tape not sticking on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949984 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949983 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949982 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the tape not sticking on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949977 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948964 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946771 ↗InjurySep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leakage at quick release on(b)(6)2026. The patient reported high BG for which there was no change to regular treatment regimen.
Patient problems: Hyperglycemia
MAUDE report 50945444 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944908 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944906 ↗InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to due to sweating and skin irritation which led to high blood glucose event and treated with manual injection.
Patient problems: Hyperglycemia; Skin Inflammation/ Irritation
MAUDE report 50944537 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to hot weather.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944536 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943778 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943769 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928592 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50927785 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set fell off due to sweat on 29 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927733 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909986 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909862 ↗MalfunctionSep 26, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907945 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907137 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient had experienced infusion set came off due to getting pulled out by clothing event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894742 ↗MalfunctionSep 25, 2026Complete Blockage
The patient reported Insulin Flow Blocked alarm, Insulin does not exist the tubing on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894588 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set fell off due to heat and perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894199 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set fell off due to heat and perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894047 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient experienced major infusion set leakage leading to insulin pockets at the insertion site event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877688 ↗
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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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