Medtronic Extended MMT-442AJRecalls & 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, used for subcutaneous infusion, has 211 adverse event reports, with no deaths and 24 injuries. Reports often describe the set falling off, its adhesive failing to hold, leaks, or the set separating during use, and some mention high blood sugar. Reports have risen sharply over the past year. 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
- 299
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 299 adverse event reports that list this exact device (DI 05705244023079), received between Jul 27, 2023 and Sep 30, 2026 — classified as 38 injuries, 261 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (108 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 Bond108
- Premature Separation85
- Leak/Splash55
- Use of Incorrect Control/Treatment Settings46
- Adverse Event Without Identified Device or Use Problem22
- Detachment of Device or Device Component19
- Fluid/Blood Leak16
- Infusion or Flow Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions233
- Hyperglycemia56
- Hemorrhage/Blood Loss/Bleeding4
- Pain3
- Skin Inflammation/ Irritation2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Erythema1
- Skin Infection1
Recent adverse event reports
The 25 most recent of 299 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 50949591 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced high blood glucose due to an infusion set leak at the insertion site on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50945648 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape not sticking along with bleeding on infusion set event on (b)(6) 2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50944900 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to perspiration on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942821 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event with infusion set where infusion set tape not sticking due to perspiration on(b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931109 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929957 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929145 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927801 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914442 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient reported infusion set came off event occurred on 28-Aug-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913402 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient reported infusion set came off event occurred on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913322 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set fell off from the insertion site, which resulted in a high blood glucose level of 22.2 mmol/L on (b)(6) 2026, and the issue was treated with a bolus.
Patient problems: Hyperglycemia
MAUDE report 50912714 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced adhesive issues on (b)(6) 2026 as infusion set came off due to unknown reasons.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911568 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909516 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909501 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908251 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908241 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908237 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908235 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907433 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50907365 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50907268 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907135 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907048 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Hyperglycemia
MAUDE report 50907046 ↗
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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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