Medtronic Extended MMT-441AGRecalls & 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 that delivers insulin under the skin. Most reports describe sets coming off the skin or failing to stick, and many describe leaks at the site. The FDA database lists 1,277 reports, with 271 injuries and 7 deaths, and reports rose sharply in the last 12 months, to 1,143 from 124. 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
- 2,000
- Deaths reported
- 7
- Injuries reported
- 451
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,000 adverse event reports that list this exact device (DI 05705244023529), received between Aug 16, 2024 and Sep 30, 2026 — classified as 7 deaths, 451 injuries, 1,542 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (857 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 Separation857
- Loss of or Failure to Bond828
- Adverse Event Without Identified Device or Use Problem313
- Use of Incorrect Control/Treatment Settings247
- Leak/Splash231
- Fluid/Blood Leak139
- Detachment of Device or Device Component47
- Infusion or Flow Problem35
Patient problems
- No Clinical Signs, Symptoms or Conditions1,375
- Hyperglycemia456
- Hypoglycemia67
- Hemorrhage/Blood Loss/Bleeding35
- Elevated Ketones/ Diabetic Ketoacidosis27
- Skin Inflammation/ Irritation20
- Skin Infection19
- Pain15
Recent adverse event reports
The 25 most recent of 2,000 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 patient faced an event where tape was not sticking on(b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951056 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950643 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950640 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the two tapes not sticking on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949599 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949597 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949272 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set tape not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948205 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking on (b)(6) 2026 due to sweat.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947280 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent resulted in Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947266 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape adhesion issue on (b)(6) 2026, as the patch came loose due to sweat at the insertion site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947081 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set was leaking at the quick release on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945439 ↗MalfunctionSep 30, 2026Premature Separation
It was reported by the patient that infusion set falling off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945209 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking as it was fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944903 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set fell off as the tubing bumped in the toilet wall on (b)(6)2026 which led to high blood glucose and no treatment was provided
Patient problems: Hyperglycemia
MAUDE report 50944742 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was pulled accidentally while sleeping on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944734 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set fell off as the infusion set was accidentally bumped into a furniture on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944729 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set tape was not sticking due to got caught on the door handle on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944617 ↗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 sweating which led to high blood glucose event (387 mg/dL).
Patient problems: Hyperglycemia
MAUDE report 50944535 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the issue with infusion set tape sticking on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943783 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set tape did not adhere while driving, and two replacement infusion sets were requested following an accident on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943765 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set tape did not adhere while driving, and two replacement infusion sets were requested following an accident on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943756 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set was pulled off while the patient was taking a shower on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943755 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's infusion set was pulled off while the patient was taking a shower on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943748 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942653 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942651 ↗
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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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