Autosoft XC 1003912Recalls & 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 Autosoft XC (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical Autosoft XC infusion set, a single-use tube set for delivering fluids under the skin, appears in 677 adverse event reports, with no deaths and 70 injuries. Reports mostly describe tubing that twisted or bent, leaks, and parts coming apart, with patients reporting high blood sugar and, in some cases, diabetic ketoacidosis. There are no recalls that 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
- 765
- Deaths reported
- 0
- Injuries reported
- 113
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 765 adverse event reports that list this exact device (DI 05705244021099), received between Jul 7, 2021 and Sep 29, 2026 — classified as 113 injuries, 652 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (360 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent360
- Loss of or Failure to Bond107
- Leak/Splash97
- Premature Separation67
- Detachment of Device or Device Component57
- Infusion or Flow Problem31
- Complete Blockage27
- Device Handling Problem27
Patient problems
- No Clinical Signs, Symptoms or Conditions387
- Hyperglycemia305
- Elevated Ketones/ Diabetic Ketoacidosis58
- Skin Inflammation/ Irritation8
- Hemorrhage/Blood Loss/Bleeding6
- Polydipsia6
- Pain5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 765 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935211 ↗MalfunctionSep 26, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907789 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set patch did not stick to skin upon insertion, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894986 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced that the infusion set tubing pulled off accidentally by getting caught on some object during use event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894443 ↗MalfunctionSep 23, 2026Tear, Rip or Hole in Device Packaging
It was reported that patient experienced infusion sets boxes are damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870242 ↗MalfunctionSep 23, 2026Tear, Rip or Hole in Device Packaging
It was reported that patient experienced infusion sets boxes are damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870218 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828270 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828254 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828245 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828142 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828102 ↗InjurySep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Hyperglycemia
MAUDE report 50826359 ↗InjurySep 18, 2026Detachment of Device or Device Component
Patient problems: Hyperglycemia
MAUDE report 50825360 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825185 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50824951 ↗InjurySep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Hyperglycemia
MAUDE report 50823427 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822059 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792565 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792562 ↗MalfunctionSep 16, 2026Leak/Splash
It was reported that the patient experienced infusion set tubing was leaking at the site event on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792383 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792374 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792368 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792365 ↗MalfunctionSep 16, 2026Leak/Splash
It was reported that the patient experienced infusion set tubing was leaking at the site event on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792361 ↗MalfunctionSep 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792025 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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