Medtronic Extended MMT-443AKRecalls & 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
- 21
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05705244025530), received between Aug 3, 2026 and Sep 30, 2026 — classified as 8 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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 Bond14
- Premature Separation14
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Hyperglycemia8
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported by that patient that the tape was not sticking for infusion set because while walking on stairs, somehow the infusion set was loose causing high blood glucose and was treated with manual insulin on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50943262 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape not sticking event due to shoveling event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941935 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877325 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877320 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877319 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via manual bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877315 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via manual bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877305 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and was treated via manual bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50877298 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50821816 ↗MalfunctionAug 17, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50277755 ↗MalfunctionAug 17, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275021 ↗MalfunctionAug 17, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269379 ↗MalfunctionAug 17, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269378 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265653 ↗MalfunctionAug 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off due to sweating event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50265643 ↗MalfunctionAug 11, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208783 ↗MalfunctionAug 11, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208781 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151713 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151703 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137237 ↗MalfunctionAug 3, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111429 ↗
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