Medtronic Extended MMT-431ARecalls & 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 set for subcutaneous infusion. The reports often describe parts that come loose or separate, leaks, and patients reporting high or low blood sugar. FDA records list 5,651 reports, 3 deaths, 962 injuries and 4,684 malfunctions. No recalls name this device. Reports rose from 340 in the prior 12 months to 4,632 in the latest 12 months.
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
- 8,574
- Deaths reported
- 3
- Injuries reported
- 1,398
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,574 adverse event reports that list this exact device (DI 05705244022683), received between Jun 9, 2022 and Sep 30, 2026 — classified as 3 deaths, 1,398 injuries, 7,171 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (5,082 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 Bond5,082
- Premature Separation5,043
- Adverse Event Without Identified Device or Use Problem1,108
- Use of Incorrect Control/Treatment Settings623
- Leak/Splash462
- Detachment of Device or Device Component355
- Fluid/Blood Leak200
- Material Twisted/Bent127
Patient problems
- No Clinical Signs, Symptoms or Conditions6,915
- Hyperglycemia1,228
- Hypoglycemia213
- Elevated Ketones/ Diabetic Ketoacidosis76
- Skin Inflammation/ Irritation65
- Pain35
- Skin Infection27
- Hemorrhage/Blood Loss/Bleeding18
Recent adverse event reports
The 25 most recent of 8,574 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 50951630 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951553 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951552 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951547 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951545 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951541 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951538 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951379 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951378 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951376 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951373 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where tape was not sticking due to weather conditions on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950857 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949981 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event where an Infusion set tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949970 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on(b)(6)2026 in which infusion set cannula came loose while in use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949969 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949957 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949726 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949079 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948954 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948594 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948590 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948588 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that tape was not sticking due to weather and sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948587 ↗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 50948359 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50948355 ↗
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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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