Medtronic Extended MMT-431AJRecalls & 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 and needle that delivers medication under the skin. Of its 1,137 reports, 151 describe injuries and 986 describe malfunctions, with no deaths. Most reports describe the adhesive failing to stick or the set coming loose early, and some describe a bent cannula and high blood sugar. Reports rose to 936 in the last 12 months from 68 in the previous 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
- 1,659
- Deaths reported
- 1
- Injuries reported
- 220
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,659 adverse event reports that list this exact device (DI 05705244022928), received between Apr 7, 2022 and Sep 30, 2026 — classified as 1 death, 220 injuries, 1,438 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (919 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 Separation919
- Loss of or Failure to Bond916
- Use of Incorrect Control/Treatment Settings181
- Adverse Event Without Identified Device or Use Problem158
- Leak/Splash104
- Detachment of Device or Device Component61
- Fluid/Blood Leak48
- Infusion or Flow Problem33
Patient problems
- No Clinical Signs, Symptoms or Conditions1,364
- Hyperglycemia220
- Hypoglycemia35
- Elevated Ketones/ Diabetic Ketoacidosis14
- Hemorrhage/Blood Loss/Bleeding10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Pain3
- Fatigue2
Recent adverse event reports
The 25 most recent of 1,659 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off on 31 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950850 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950634 ↗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 50949596 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949593 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949590 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced site leakage likely caused infusion set to fall down on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949280 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948970 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced infusion set insulin flow blocked causing high blood glucose levels 2900 mg/dl and treated with insulin injection event on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947824 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose event which was treated insulin, on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946496 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set coming off due to sweating on (b)(6) 2026. The issue occurred with multiple infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945941 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient reported infusion set's leakage at site issue on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945650 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944530 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6)2026 where the infusion set tape was not sticking due to sweating.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944527 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944454 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set tape was not sticking due to sweat.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944448 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944257 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944253 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944246 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set tape not sticking event due to perspiration on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944073 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set adhesive failure on (b)(6) 2026 where the infusion set tape was not adhered.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944021 ↗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 50943784 ↗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 50943774 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly due to heat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943489 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient face issue with tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943096 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive issue, with the infusion set tape not sticking due to sweat on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942617 ↗
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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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