Medtronic Extended MMT-431AKRecalls & 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 tube that delivers insulin under the skin. Its 834 reports include 1 death and 207 injuries. Many describe parts separating too early or failing to bond, leaks at the site, and some patients reporting high blood sugar when insulin did not flow. Reports rose to 705 in the last 12 months, up from 100 in the 12 months 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
- 1,206
- Deaths reported
- 1
- Injuries reported
- 346
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,206 adverse event reports that list this exact device (DI 05705244025356), received between Jul 11, 2024 and Sep 30, 2026 — classified as 1 death, 346 injuries, 859 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (499 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 Separation499
- Loss of or Failure to Bond473
- Adverse Event Without Identified Device or Use Problem246
- Leak/Splash108
- Fluid/Blood Leak81
- Use of Incorrect Control/Treatment Settings79
- Detachment of Device or Device Component46
- Infusion or Flow Problem36
Patient problems
- No Clinical Signs, Symptoms or Conditions800
- Hyperglycemia293
- Hypoglycemia55
- Elevated Ketones/ Diabetic Ketoacidosis33
- Hemorrhage/Blood Loss/Bleeding9
- Skin Inflammation/ Irritation8
- Rash7
- Pain6
Recent adverse event reports
The 25 most recent of 1,206 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 50951564 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951563 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set tape started peeling off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951559 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949990 ↗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 50949989 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949985 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949706 ↗MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949277 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that the patient experienced an Insulin Flow Blocked alarm due to an occlusion in the infusion set/reservoir connection, with insulin unable to pass through the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949083 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50949077 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50949074 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948357 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948356 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that Infusion set tape did not stick and fell off from site insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948333 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set tape did not stick and the set fell off from the insertion site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948222 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patients that tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948215 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947102 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947096 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947095 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set was not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947072 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leakage was at the quick release on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945450 ↗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 50943734 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported infusion set tape not sticking and set fell off from site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942176 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported infusion set fell off during use due to tape not sticking on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942175 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing detachment, where the infusion set tubing became disconnected from the tubing connector attached to the reservoir on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941867 ↗
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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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