Autosoft XC 1009566Recalls & 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 infusion set has 438 adverse event reports, with 39 injuries and no deaths. The reports mostly describe tubing that is twisted or bent, along with bonding failures, flow problems, parts coming loose and leaks, and some mention high blood sugar in patients. There were 47 reports in the last 12 months, down from 219 in the 12 months before. No recalls 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
- 468
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 468 adverse event reports that list this exact device (DI 05705244026049), received between May 11, 2024 and Sep 30, 2026 — classified as 49 injuries, 419 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (292 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/Bent292
- Loss of or Failure to Bond52
- Infusion or Flow Problem25
- Detachment of Device or Device Component23
- Leak/Splash23
- Premature Separation21
- Fluid/Blood Leak13
- Material Deformation13
Patient problems
- No Clinical Signs, Symptoms or Conditions258
- Hyperglycemia171
- Elevated Ketones/ Diabetic Ketoacidosis28
- Pain9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Skin Inflammation/ Irritation2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 468 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced accidental pull-out of the two-infusion set during use due to the tubing catching on something or the pump falling on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943771 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced accidental pull-out of the two-infusion set during use due to the tubing catching on something or the pump falling on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943727 ↗InjurySep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50932101 ↗MalfunctionSep 29, 2026Partial Blockage
It was reported that the patient experienced an infusion set blockage at site event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930205 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set patch did not stick to the skin upon insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894105 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50833854 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826430 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826424 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826423 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826422 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced issue with infusion set fell off during use on and no date of event was mentioned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826406 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826393 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823436 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50822215 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50821707 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
It was reported that the patient faced an event where they mentioned infusion set tubing was leaking at the site on(b)(6)2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821176 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821171 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821160 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821045 ↗InjurySep 14, 2026Leak/Splash
It was reported that the patient had high blood glucose due to infusion set was leaking at the site and treated with insulin pump event on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50757050 ↗InjurySep 11, 2026Device Handling Problem
It was reported that patient faced cannula was bent due to site inserted into scar tissue event on (b)(6) 2026 and patient experienced high blood glucose level and treated with Correction injection via Multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50732525 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50632294 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50632280 ↗MalfunctionSep 1, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50537948 ↗InjurySep 1, 2026Use of Incorrect Control/Treatment Settings
It was reported that, on (b)(6) 2026, the infusion set was accidentally pulled out during use when the tubing became caught on an object or as a result of the pump falling, resulting in high blood glucose treated with a correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50537936 ↗
Other Set, Administration, Intravascular devices
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- 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.