Autosoft XC 1001728Recalls & 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 761 reports, with no deaths and 127 injuries. Many reports describe parts that are bent or twisted, along with leaks, parts coming loose, and adhesive that fails to hold. Many patient reports mention high blood sugar. 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
- 873
- Deaths reported
- 0
- Injuries reported
- 178
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 873 adverse event reports that list this exact device (DI 05705244016927), received between Mar 18, 2019 and Sep 30, 2026 — classified as 178 injuries, 695 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (309 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/Bent309
- Loss of or Failure to Bond134
- Leak/Splash106
- Premature Separation101
- Infusion or Flow Problem66
- Detachment of Device or Device Component62
- Use of Incorrect Control/Treatment Settings50
- Fluid/Blood Leak41
Patient problems
- No Clinical Signs, Symptoms or Conditions447
- Hyperglycemia369
- Elevated Ketones/ Diabetic Ketoacidosis55
- Hemorrhage/Blood Loss/Bleeding9
- Skin Inflammation/ Irritation2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 873 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced recurring occlusion alarms on (b)(6) 2026 associated with blockage at the infusion site and a bent/kinked cannula.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948582 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that recurring occlusion alarms associated with a kinked infusion set cannula on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948577 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that recurring occlusion alarms associated with a kinked infusion set cannula on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948574 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient experienced Infusion set adhesive patch and cannula housing detached from spring prior to insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946874 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50935806 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event in which three infusion sets fell off on (b)(6)2026. The patient went to the emergency room with a highest reported blood glucose level of 550 mg/dL and tested positive for ketones. The patient was treated with intravenous saline fluids and insulin.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50935803 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50935764 ↗InjurySep 29, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was used for three hours resulted in kinked cannula and experienced Hyperglycemia treated with Correction bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50934411 ↗InjurySep 29, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was used for 12 hours resulted in bent cannula and experienced Hyperglycemia treated with Correction bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50933852 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928272 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928189 ↗InjurySep 27, 2026Complete Blockage
Patient problems: Hyperglycemia
MAUDE report 50909472 ↗MalfunctionSep 25, 2026Material Twisted/Bent
It was reported that patient experienced that the infusion set cannula being kinked upon removal from the insertion site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894436 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced an event where an infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877631 ↗InjurySep 24, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient faced an issue were the infusion set cannula was kinked which led to high blood glucose and was treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50877055 ↗InjurySep 22, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced cannula kinked event with four infusion sets on (b)(6) 2026 along with high blood glucose which was addressed by correction bolus.
Patient problems: Hyperglycemia
MAUDE report 50852937 ↗InjurySep 22, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced cannula kinked event with four infusion sets on (b)(6) 2026 along with high blood glucose which was addressed by correction bolus.
Patient problems: Hyperglycemia
MAUDE report 50852930 ↗InjurySep 22, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced cannula kinked event with four infusion sets on(b)(6)2026 along with high blood glucose which was addressed by correction bolus.
Patient problems: Hyperglycemia
MAUDE report 50852929 ↗InjurySep 22, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced cannula kinked event with four infusion sets on (b)(6) 2026 along with high blood glucose which was addressed by correction bolus.
Patient problems: Hyperglycemia
MAUDE report 50852926 ↗InjurySep 20, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50834663 ↗InjurySep 20, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50834661 ↗InjurySep 20, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50834660 ↗MalfunctionSep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50827443 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827322 ↗MalfunctionSep 18, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826690 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.