Autosoft XC 1001729Recalls & 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 Autosoft XC infusion set is a single-use tube set that delivers medication under the skin. Its 729 reports mostly describe malfunctions such as bent or twisted tubing, parts that fail to stay bonded, leaks and detachment, and many describe high blood sugar. The reports mention no deaths and 86 injuries, and reports rose from 165 in the prior 12 months to 250 in the latest 12 months. 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
- 849
- Deaths reported
- 0
- Injuries reported
- 116
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 849 adverse event reports that list this exact device (DI 05705244016958), received between Dec 13, 2018 and Sep 30, 2026 — classified as 116 injuries, 733 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (214 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/Bent214
- Loss of or Failure to Bond210
- Leak/Splash127
- Premature Separation118
- Detachment of Device or Device Component67
- Infusion or Flow Problem58
- Fluid/Blood Leak46
- Complete Blockage32
Patient problems
- No Clinical Signs, Symptoms or Conditions472
- Hyperglycemia324
- Elevated Ketones/ Diabetic Ketoacidosis36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Hemorrhage/Blood Loss/Bleeding8
- Pain2
- Angina1
- Dehydration1
Recent adverse event reports
The 25 most recent of 849 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set patch did not stick to skin upon insertion with five infusion sets event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945054 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set patch did not stick to skin upon insertion with five infusion sets event on (b)(6) 2026 and (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945053 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set patch did not stick to skin upon insertion with five infusion sets event on 01 Sep 2026 and 02 Sep 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945051 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set patch did not stick to skin upon insertion with five infusion sets event on (b)(6) 2026 and (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945050 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced infusion set patch did not stick to skin upon insertion with five infusion sets event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945032 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50935794 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced ten infusion sets fell off event on (b)(6) 2026 during use along with high blood glucose which was treated with correction injection via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50935781 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929044 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908306 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908305 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908303 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908296 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908295 ↗InjurySep 26, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50908293 ↗InjurySep 26, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50907831 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907216 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907176 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907171 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907166 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907159 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906928 ↗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 50894896 ↗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 50894885 ↗InjurySep 24, 2026Complete Blockage
It was reported that the patient experienced an insulin occlusion event which led to high blood glucose. The event was treated with a correction bolus via pump. Troubleshooting determined that the blockage was located in the infusion set tubing. The patient later reported visiting an urgent care facility on (b)(6) 2026 for dehydration and received intravenous saline solution.
Patient problems: Dehydration; Hyperglycemia
MAUDE report 50877528 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event of infusion set patch did not stick to skin upon insertion. Insertion site was abdomen
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864637 ↗
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.