Medtronic Extended MMT-433AGRecalls & 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
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 05705244023468), received between Mar 17, 2026 and Sep 30, 2026 — classified as 6 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (20 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 Separation20
- Loss of or Failure to Bond18
- Use of Incorrect Control/Treatment Settings12
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available1
- Failure to Fire1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Pain4
- Hyperglycemia3
- Hypoglycemia2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50947612 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced 2 infusion sets being pulled out by accident after the tubing got caught in a chair on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893168 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced 2 infusion sets being pulled out by accident after the tubing got caught in a chair on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893150 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced an infusion set falling off while stretching on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893149 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that infusion set adhesive/tape was not sticking and fell off on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864067 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set is no longer sticking on his abdomen on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841217 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841212 ↗MalfunctionSep 18, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828026 ↗InjurySep 18, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced an event where infusion set came off due to run off by clothing on (b)(6) 2026. which led to high blood glucose and treated with insulin injection.
Patient problems: Hyperglycemia
MAUDE report 50823618 ↗MalfunctionSep 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Pain
MAUDE report 50745955 ↗MalfunctionSep 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Pain
MAUDE report 50745952 ↗MalfunctionSep 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Pain
MAUDE report 50745927 ↗MalfunctionSep 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Pain
MAUDE report 50745924 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610373 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610369 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50609354 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493453 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493445 ↗MalfunctionAug 26, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient has experienced infusion set fell off due to tape not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449668 ↗MalfunctionAug 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced pulling off of Infusion Set during use event on 17 Jun 2026 as the patient accidentally twisted the infusion set tubing in the wrong direction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50426244 ↗MalfunctionAug 17, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268664 ↗MalfunctionAug 16, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265761 ↗MalfunctionAug 11, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205246 ↗MalfunctionAug 11, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205008 ↗MalfunctionAug 11, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced falling off of infusion set from the site event on (b)(6) 2026 due to perspiration and the infusion set was bumped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205007 ↗
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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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