Medtronic Extended MMT-431AGRecalls & 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, used for subcutaneous infusion, has 2,225 reports, which include 12 deaths and 471 injuries. Most describe the set coming loose or its tape not sticking, and some describe leaks at the site. Reports also mention high blood sugar. No recalls name this device. Reports rose to 1,802 in the last 12 months from 342 in the previous 12.
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
- 3,397
- Deaths reported
- 14
- Injuries reported
- 751
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,397 adverse event reports that list this exact device (DI 05705244023406), received between Jul 18, 2024 and Sep 30, 2026 — classified as 14 deaths, 751 injuries, 2,632 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (1,461 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 Separation1,461
- Loss of or Failure to Bond1,393
- Adverse Event Without Identified Device or Use Problem526
- Use of Incorrect Control/Treatment Settings401
- Leak/Splash355
- Fluid/Blood Leak207
- Detachment of Device or Device Component121
- Infusion or Flow Problem85
Patient problems
- No Clinical Signs, Symptoms or Conditions2,425
- Hyperglycemia676
- Hypoglycemia135
- Elevated Ketones/ Diabetic Ketoacidosis84
- Skin Inflammation/ Irritation38
- Hemorrhage/Blood Loss/Bleeding24
- Pain9
- Bruise/Contusion8
Recent adverse event reports
The 25 most recent of 3,397 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 50951646 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the tape not sticking due to the patient went into the water on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951551 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951540 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off due to shower on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951053 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950856 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950852 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950658 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950637 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950636 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949718 ↗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 50949716 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949713 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949071 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948965 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced tape not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948957 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948726 ↗MalfunctionSep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a bent infusion set cannula and blood at the insertion site, resulting in bleeding, bruising, and pain at the side of the thigh on (b)(6) 2026.
Patient problems: Bruise/Contusion; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50948715 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set fell off due to got caught on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948339 ↗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 50948211 ↗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 50948207 ↗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 50947284 ↗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 swimming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947282 ↗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 swimming.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947273 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event on (b)(6) 2026, as the tape peeled up on the sides.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947092 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking during sleep event on(b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947086 ↗
Other Set, Administration, Intravascular devices
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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