Medtronic Extended MMT-442AGRecalls & 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 infusion set for delivering fluid under the skin. Its 713 reports, including 2 deaths and 127 injuries, mostly describe parts separating, adhesive failing to bond, and leaks. Patients in these reports mention high and low blood sugar, and a few mention high ketone levels. No recalls name this device, and reports in the last 12 months number 584, up from 99 in the year before.
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
- 1,073
- Deaths reported
- 2
- Injuries reported
- 213
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,073 adverse event reports that list this exact device (DI 05705244023550), received between Jul 26, 2024 and Sep 30, 2026 — classified as 2 deaths, 213 injuries, 858 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (437 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 Separation437
- Loss of or Failure to Bond410
- Leak/Splash157
- Adverse Event Without Identified Device or Use Problem128
- Use of Incorrect Control/Treatment Settings100
- Fluid/Blood Leak74
- Infusion or Flow Problem41
- Material Twisted/Bent38
Patient problems
- No Clinical Signs, Symptoms or Conditions795
- Hyperglycemia197
- Hypoglycemia41
- Elevated Ketones/ Diabetic Ketoacidosis18
- Hemorrhage/Blood Loss/Bleeding15
- Skin Infection5
- Pain4
- Confusion/ Disorientation3
Recent adverse event reports
The 25 most recent of 1,073 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951930 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50951644 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where tape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950845 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the product not adhering due to perspiring but should not be enough to make the product not adhering on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949717 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948967 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948966 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that ape was not sticking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948204 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced high blood glucose of 291 mg/dL for greater than 4 hours. Troubleshooting revealed the infusion set cannula was bent, the event was treated using insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50945924 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set was leaking at the site and patient has declined to troubleshoot on (b)(6) 2026. The blood glucose level was 282 mg/dL and infusion set was changed and there was no change to regular treatment regimen.
Patient problems: Hyperglycemia
MAUDE report 50945442 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set tape was not adhering properly on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943785 ↗InjurySep 30, 2026Fluid/Blood Leak
On (b)(6)2026, the infusion set leaked directly at the insertion site, causing the patient's blood sugar to rise to 259 mg/dL. The patient treated the high blood sugar by replacing the infusion set and taking a correction dose of insulin via injection.
Patient problems: Hyperglycemia
MAUDE report 50942613 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient infusion set tape not sticking due to swimming on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942599 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive issue, with the infusion set tape not sticking due to perspiration and being removed on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942579 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set fell off due to weather on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942151 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50929976 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the patient that high blood glucose and experienced symptoms such as nausea and stomach pain and treated it with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50928659 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the patient that high blood glucose and was treated with pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50928624 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928578 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927940 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that infusion set fell off on (b)(6)2026 and did not last for 7 days.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927788 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that infusion set fell off on (b)(6) 2026 and did not last for 7 days.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927779 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set fell off during use on (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927709 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50927634 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50927628 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set fell off due to sweat on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914439 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page