Medtronic Extended MMT-443AJRecalls & 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
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 05705244023109), received between Jan 4, 2024 and Sep 25, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (19 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 Bond19
- Premature Separation19
- Detachment of Device or Device Component4
- Fluid/Blood Leak2
- Leak/Splash2
- Use of Incorrect Control/Treatment Settings2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Hyperglycemia5
- Pain5
- Skin Infection5
- Skin Inflammation/ Irritation5
- Cellulitis1
- Hemorrhage/Blood Loss/Bleeding1
- Rash1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that infusion set tape was not sticking due to perspiration on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894099 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive not sticking event on (b)(6) 2026 with sore spots at the site.
Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation
MAUDE report 50864625 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive not sticking event on (b)(6)2026 with sore spots at the site.
Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation
MAUDE report 50864622 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive not sticking event on (b)(6) 2026 with sore spots at the site.
Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation
MAUDE report 50864612 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive not sticking event on (b)(6) 2026 with sore spots at the site.
Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation
MAUDE report 50864610 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an adhesive not sticking event on (b)(6)2026 with sore spots at the site.
Patient problems: Pain; Skin Infection; Skin Inflammation/ Irritation
MAUDE report 50864608 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a hyperglycemia event and treated with manual injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50863721 ↗MalfunctionSep 12, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746339 ↗MalfunctionSep 12, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746338 ↗MalfunctionSep 12, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745634 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where they mentioned infusion set fell off when the patient was on vacation and on a country that is humid that exposed the site location on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470606 ↗MalfunctionAug 17, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding; Rash
MAUDE report 50273745 ↗MalfunctionAug 9, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188181 ↗MalfunctionAug 9, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188180 ↗MalfunctionAug 9, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188179 ↗MalfunctionAug 9, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set fell off on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188173 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117662 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117657 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117655 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111121 ↗MalfunctionApr 22, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT REPORTED INFUSION SET CAME OFF AFTER SHOWERING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956225 ↗MalfunctionApr 15, 2026Fluid/Blood Leak
IT WAS REPORTED THAT INFUSION SET WAS LEAKING AT THE SITE ON (B)(6) 2026 AND HAS BEEN IN USE FOR THREE DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24880989 ↗MalfunctionApr 9, 2026Loss of or Failure to Bond; Premature Separation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825629 ↗MalfunctionApr 4, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THAT THE PATIENT FACED TAPE NOT STICKING ISSUE DUE TO INFUSION SET WAS ACCIDENTALLY PULLED OUT DURING WORK ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784805 ↗MalfunctionMar 26, 2026Leak/Splash
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT SITE ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701248 ↗
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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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