Autosoft XC 1001683Recalls & 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
Quick summary
This Unomedical Autosoft XC is a single-use infusion set for delivering fluid under the skin. Many reports describe twisted or bent tubing, adhesive that fails to bond, and leaks, and some mention high blood sugar. The records include 1,953 reports, 194 injuries and no deaths, and no recalls name this device. Reports fell from 586 in the year before to 138 in the most recent year.
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
- 1,975
- Deaths reported
- 0
- Injuries reported
- 208
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,975 adverse event reports that list this exact device (DI 05705244016712), received between May 10, 2019 and Sep 29, 2026 — classified as 208 injuries, 1,767 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,197 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1,197
- Loss of or Failure to Bond273
- Leak/Splash192
- Infusion or Flow Problem114
- Detachment of Device or Device Component74
- Device Handling Problem39
- Fluid/Blood Leak25
- Complete Blockage20
Patient problems
- No Clinical Signs, Symptoms or Conditions917
- Hyperglycemia865
- Elevated Ketones/ Diabetic Ketoacidosis159
- Hemorrhage/Blood Loss/Bleeding15
- Hypoglycemia10
- Pain7
- Unspecified Infection6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 1,975 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50928748 ↗InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced ten infusion set cannula kinked events on (b)(6)2026. The blood glucose level was high, and the patient was treated with correction bolus via pump and multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50928658 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient faced an event of kinked cannula which led to alarms after three hours of use and insulin flow blocked on 18-Aug-2026. Insertion site was Upper buttocks.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894762 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826506 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821212 ↗MalfunctionSep 18, 2026Leak/Splash
It was reported that the patient faced an event where they mentioned leakage at the site on (b)(6)2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821165 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821151 ↗InjurySep 18, 2026Fluid/Blood Leak
It was reported that the patient faced an event where they mentioned high blood glucose level and managed it with correction bolus via pump and infusion set tubing was leaking at the site on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50821150 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821103 ↗InjurySep 18, 2026Fluid/Blood Leak
It was reported that the patient faced an event where they mentioned high blood glucose level and managed it with correction bolus via pump and infusion set tubing was leaking at the site on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50821058 ↗InjurySep 18, 2026Fluid/Blood Leak
It was reported that the patient faced an event of infusion set tubing was leaked from site on (b)(6) 2025. which causes high blood glucose levels corrected via MDI.
Patient problems: Hyperglycemia
MAUDE report 50821033 ↗InjurySep 5, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50632284 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50632278 ↗InjurySep 5, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50632276 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
It was reported by the patient that the infusion set fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610861 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50610842 ↗InjurySep 2, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50568135 ↗InjuryAug 31, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50518484 ↗InjuryAug 31, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced three infusion sets was tightly wound around itself and would not allow itself to unwind smoothly without causing a premature detachment leading to elevated blood glucose and was treated with correction injection via multiple daily injections on (b)(6) 2023.
Patient problems: Hyperglycemia
MAUDE report 50518165 ↗InjuryAug 31, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced three infusion sets was tightly wound around itself and would not allow itself to unwind smoothly without causing a premature detachment leading to elevated blood glucose and was treated with correction injection via multiple daily injections on (b)(6) 2023.
Patient problems: Hyperglycemia
MAUDE report 50518035 ↗MalfunctionAug 31, 2026Use of Incorrect Control/Treatment Settings; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518033 ↗MalfunctionAug 31, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50515388 ↗InjuryAug 31, 2026Leak/Splash
It was reported that the patient faced an event where they mentioned High Blood Glucose which was treated with manual injection and infusion set leakage at the site on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50515319 ↗MalfunctionAug 26, 2026Leak/Splash
Patient problems: Hypoglycemia
MAUDE report 50457559 ↗MalfunctionAug 26, 2026Leak/Splash
Patient problems: Hypoglycemia
MAUDE report 50457499 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.