Medtronic Extended MMT-432AGRecalls & 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 has 249 reports on file, with 1 death and 34 injuries. Many describe the set coming off or separating early, sometimes linked to perspiration, and others describe leaks or failures to bond, while some patients mention high blood sugar. No recalls name this device, and reports rose to 220 in the latest year from 23 in the year before.
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
- 356
- Deaths reported
- 1
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 05705244023437), received between Aug 5, 2024 and Sep 30, 2026 — classified as 1 death, 63 injuries, 292 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (147 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 Separation147
- Loss of or Failure to Bond139
- Use of Incorrect Control/Treatment Settings54
- Adverse Event Without Identified Device or Use Problem46
- Leak/Splash42
- Detachment of Device or Device Component14
- Fluid/Blood Leak14
- Material Twisted/Bent11
Patient problems
- No Clinical Signs, Symptoms or Conditions261
- Hyperglycemia65
- Pain10
- Hypoglycemia9
- Elevated Ketones/ Diabetic Ketoacidosis7
- Hemorrhage/Blood Loss/Bleeding4
- Vomiting4
- Skin Inflammation/ Irritation3
Recent adverse event reports
The 25 most recent of 356 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949269 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that the infusion set came off due to tape is not sticky on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949085 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947830 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient's extended infusion set was accidentally pulled out by a child during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943761 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set coming off the skin event on (b)(6) 2026 due to sweating along with high blood glucose which was treated by delivering a bolus using the pump.
Patient problems: Hyperglycemia
MAUDE report 50936473 ↗MalfunctionSep 29, 2026Partial Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927798 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917857 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50915560 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50915551 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced detachment of Infusion Set while using event on (b)(6) 2026. The patient also faced low blood glucose event.
Patient problems: Hypoglycemia
MAUDE report 50912968 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set was not sticking at site due to Perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912125 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908205 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907598 ↗MalfunctionSep 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907582 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907549 ↗MalfunctionSep 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907521 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907497 ↗MalfunctionSep 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907431 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906920 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50906884 ↗MalfunctionSep 25, 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 50897270 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient had pain at insertion site due to infusion set cannula was bent event on (b)(6) 2026.
Patient problems: Pain
MAUDE report 50895390 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient had high blood glucose and treated with Insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50895356 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced infusion set came off event on 25-Aug-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894980 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced infusion set tubing detachment after the tubing was pulled while changing clothes on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893116 ↗
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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