Medtronic Extended MMT-432ARecalls & 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 that delivers medication under the skin. Its 334 reports mostly describe the set failing to stay attached to the skin or coming apart early, with leaks and some patients reporting high blood sugar. The reports mention 2 deaths and 48 injuries. Reports rose from 31 in the prior 12 months to 267 in the latest 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
- 487
- Deaths reported
- 2
- Injuries reported
- 78
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 487 adverse event reports that list this exact device (DI 05705244022713), received between May 5, 2023 and Sep 30, 2026 — classified as 2 deaths, 78 injuries, 407 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (239 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 Bond239
- Premature Separation239
- Adverse Event Without Identified Device or Use Problem63
- Use of Incorrect Control/Treatment Settings52
- Leak/Splash45
- Detachment of Device or Device Component20
- Fluid/Blood Leak20
- Complete Blockage10
Patient problems
- No Clinical Signs, Symptoms or Conditions397
- Hyperglycemia61
- Hypoglycemia20
- Hypersensitivity/Allergic reaction4
- Elevated Ketones/ Diabetic Ketoacidosis2
- Abscess1
- Coma1
- Nausea1
Recent adverse event reports
The 25 most recent of 487 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 50951558 ↗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 50949080 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948973 ↗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 50948341 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944740 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944613 ↗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 50943092 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion sets falling off due to heat event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942060 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion sets falling off due to heat event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942048 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape was not sticking due to sweat event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941930 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape was not sticking event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941903 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape was not sticking due to water event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941862 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934728 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient faced an event where Blood glucose levels were high and insulin pen was used for treatment on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50932626 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931227 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931110 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50930401 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hypoglycemia
MAUDE report 50927826 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50923455 ↗MalfunctionSep 28, 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 heat/ perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913064 ↗MalfunctionSep 28, 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 heat/ perspiration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913060 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set tape stopped sticking due to heat and perspiration on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912775 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set came loose because heat and sweat made the tape stop sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912760 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set tape stopped sticking due to heat and perspiration on 28-Aug-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912726 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set tape stopped sticking due to sweat from playing sports on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912707 ↗
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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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