Medtronic Extended MMT-443AGRecalls & 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 is a Medtronic Extended MMT-443AG infusion set, a single-use set placed under the skin to deliver insulin or similar medicine over several days. The 44 reports mostly describe the set coming apart or its adhesive letting go too early, along with leaking at the site; several mention high blood sugar as a result. No deaths were reported, and 8 injuries. There are no recalls naming 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
- 105
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 05705244023581), received between Mar 23, 2026 and Sep 30, 2026 — classified as 24 injuries, 81 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (45 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 Separation45
- Loss of or Failure to Bond43
- Use of Incorrect Control/Treatment Settings20
- Adverse Event Without Identified Device or Use Problem13
- Fluid/Blood Leak11
- Device Handling Problem7
- Leak/Splash5
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Hyperglycemia26
- Hypoglycemia2
- Skin Infection1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that the patient faced infusion set tubing came apart on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945660 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942152 ↗InjurySep 29, 2026Device Handling Problem
It was reported that patient face issue with air bubbles due insulin vial was not at room temperature and high blood glucose treated with insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50927947 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient Infusion set suddenly fell off after inserted and went to bathroom on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917860 ↗MalfunctionSep 27, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909609 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907694 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907457 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907451 ↗MalfunctionSep 25, 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 due to sweat and set leakage at site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894072 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event of hypoglycemia treated by glucose tablets soda drink on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50893100 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced an event of hypoglycemia treated by glucose tabs, soda on (b)(6) 2026.
Patient problems: Hypoglycemia
MAUDE report 50893098 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient faced high blood glucose treated with insulin pump, event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50880841 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose on the fifth day of infusion set wear on (b)(6) 2026, the event was treated by changing the infusion set and administering a bolus via the pump.
Patient problems: Hyperglycemia
MAUDE report 50877896 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose on the fifth day of infusion set wear on (b)(6) 2026, the event was treated by changing the infusion set and administering a bolus via the pump.
Patient problems: Hyperglycemia
MAUDE report 50877891 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose on the fifth day of infusion set wear on (b)(6) 2026, the event was treated by changing the infusion set and administering a bolus via the pump.
Patient problems: Hyperglycemia
MAUDE report 50877788 ↗InjurySep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set fell off from the site on fifth day of use and patient experienced hyperglycemia which was treated by bolus and manual shots on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50864780 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
The patient reported infusion set tape was not sticking and fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864084 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set tape is not sticking and irritation and pus at the site on (b)(6)2026.
Patient problems: Skin Infection
MAUDE report 50837933 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834513 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834511 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834493 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834489 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834477 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834474 ↗MalfunctionSep 20, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834473 ↗
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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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