Medtronic Extended MMT-441AJRecalls & 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 that delivers medication under the skin. Its 331 reports mostly describe the set coming apart or not staying attached, leaks and high blood sugar in many patients. The reports mention 1 death and 66 injuries. Reports rose from 23 in the prior 12 months to 210 in the latest 12 months. 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
- 449
- Deaths reported
- 1
- Injuries reported
- 102
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 449 adverse event reports that list this exact device (DI 05705244023048), received between May 10, 2024 and Sep 30, 2026 — classified as 1 death, 102 injuries, 346 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (178 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 Bond178
- Premature Separation152
- Leak/Splash90
- Adverse Event Without Identified Device or Use Problem59
- Use of Incorrect Control/Treatment Settings26
- Fluid/Blood Leak18
- Complete Blockage14
- Detachment of Device or Device Component14
Patient problems
- No Clinical Signs, Symptoms or Conditions310
- Hyperglycemia104
- Hypoglycemia16
- Hemorrhage/Blood Loss/Bleeding9
- Elevated Ketones/ Diabetic Ketoacidosis6
- Unspecified Infection2
- Abscess1
- Anxiety1
Recent adverse event reports
The 25 most recent of 449 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced the infusion set becoming loose after the tubing caught on a door, leading to high blood glucose on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50943762 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking because of sweating due to humidity on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942829 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking because of sweating due to humidity on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942828 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking because of sweating due to humidity on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942825 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking because of sweating due to humidity on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942789 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking because of sweating due to humidity on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942606 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hypoglycemia of 67 mg/dL event with symptoms of dizziness and weakness on (b)(6)2026 which was corrected with sugar water.
Patient problems: Dizziness; Hypoglycemia
MAUDE report 50942194 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set leakage at the site with two infusion sets on the first day of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941826 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set leakage at the site with two infusion sets on the first day of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941825 ↗MalfunctionSep 30, 2026Partial Blockage; Fluid/Blood Leak
It was reported that the infusion set tubing detached from the reservoir connection on (b)(6) 2026 resulting in an Insulin Flow Blocked alarm after using for Less than 7 days.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941785 ↗MalfunctionSep 29, 2026Partial Blockage; Leak/Splash; Material Twisted/Bent
It was reported that patient experienced an event on (b)(6)2026 where infusion set cannula was bent and leak which leads to bleeding at site.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50936123 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50915333 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913217 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Material Twisted/Bent; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912705 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909895 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909608 ↗MalfunctionSep 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907965 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907791 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose event on (b)(6) 2026 which was addressed by bolus.
Patient problems: Hyperglycemia
MAUDE report 50896074 ↗MalfunctionSep 25, 2026Leak/Splash
It was reported that the patient experienced a leakage at the infusion set insertion site on(b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894611 ↗MalfunctionSep 25, 2026Leak/Splash
It was reported that the patient experienced a leakage at the infusion set insertion site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894608 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set fell off while taking shower on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894062 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced hypoglycemia event on (b)(6) 2026 which was corrected with Glucose shot.
Patient problems: Hypoglycemia
MAUDE report 50880859 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape was not sticking due to water exposure on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877799 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient reported that his infusion set was leaking at the site and infusion set had been in use for three days on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877694 ↗
Other Set, Administration, Intravascular devices
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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