Medtronic Extended MMT-432AJRecalls & 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 Unomedical Extended MMT-432AJ is a single-use infusion set that sits under the skin to deliver insulin. The 49 reports mostly describe the set coming apart too early or its parts not bonding properly, along with leaking fluid or blood at the site and insulin not flowing through the tubing. Three injuries were reported and no deaths. There are no recalls naming this device. Reports rose sharply in the past 12 months, from 8 to 38.
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
- 79
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 05705244022959), received between May 20, 2024 and Sep 29, 2026 — classified as 8 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (38 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 Bond38
- Premature Separation38
- Fluid/Blood Leak9
- Leak/Splash8
- Use of Incorrect Control/Treatment Settings7
- Adverse Event Without Identified Device or Use Problem5
- Detachment of Device or Device Component4
- Infusion or Flow Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- Hyperglycemia9
- Elevated Ketones/ Diabetic Ketoacidosis2
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934883 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928574 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50915568 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event of tape not sticking issue on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912549 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event of tape not sticking issue on(b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912548 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced Infusion set falling off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887632 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that, on (b)(6) 2026, the patient experienced an event where the infusion set came off while doing laundry and it rubbed against something.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877620 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set fell off due to set got wet on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866250 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced that infusion set fell off due to set got wet on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866249 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced elevated blood glucose levels event on (b)(6) 2026 and was treated with manual injection.
Patient problems: Hyperglycemia
MAUDE report 50865865 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where tape did not stick and infusion set fell off due to moisture on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863375 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose of and treated with manual insulin event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50850167 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50837929 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837245 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834334 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824364 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where infusion set fell came off due to sweat caused by hot weather on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824314 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where infusion set fell came off after taking a shower and sweating due to hot weather on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824311 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823567 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50822298 ↗MalfunctionSep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822106 ↗MalfunctionSep 7, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652821 ↗MalfunctionSep 7, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50643946 ↗MalfunctionSep 7, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50643945 ↗MalfunctionSep 7, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50643944 ↗
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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