Autosoft XC 1010899Recalls & 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 subcutaneous use. Of the 609 reports naming it, many describe tubing that is twisted or bent, leaking at the site, or coming apart early. Several reports describe patients with high blood glucose after a leak, and the reports include 66 injuries and no deaths. 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
- 616
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 616 adverse event reports that list this exact device (DI 05705244025981), received between Feb 12, 2024 and Sep 25, 2026 — classified as 74 injuries, 542 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (260 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/Bent260
- Leak/Splash123
- Loss of or Failure to Bond98
- Infusion or Flow Problem56
- Detachment of Device or Device Component31
- Premature Separation17
- Adverse Event Without Identified Device or Use Problem12
- Material Deformation11
Patient problems
- Hyperglycemia286
- No Clinical Signs, Symptoms or Conditions273
- Elevated Ketones/ Diabetic Ketoacidosis25
- Hemorrhage/Blood Loss/Bleeding16
- Hypoglycemia7
- Pain3
- Skin Infection3
- Cellulitis2
Recent adverse event reports
The 25 most recent of 616 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced event where infusion set cannula was kinked during use resulting in high blood glucose (BG), which was treated with Correction bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50896131 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50826710 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced high blood glucose levels exceed 500 mg/dL due to bent cannula and was treated with injection via Multiple Daily Injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50826704 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced high blood glucose levels exceed 500 mg/dL due to bent cannula and was treated with injection via Multiple Daily Injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50826691 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50826496 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50823265 ↗MalfunctionSep 4, 2026Leak/Splash
It was reported that infusion set tubing was leaking at site on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50608584 ↗InjurySep 1, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where tape was not sticking and experienced Hyperglycemia treated with Correction injection via MDI.
Patient problems: Hyperglycemia
MAUDE report 50545941 ↗MalfunctionAug 27, 2026Leak/Splash
It was reported that infusion set tubing was leaking at site on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50467335 ↗InjuryAug 26, 2026Leak/Splash
It was reported that patient experienced high blood glucose and treated with bolus via pump on (b)(6) 2024 due to infusion set tubing was leaking at the site.
Patient problems: Hyperglycemia
MAUDE report 50446389 ↗InjuryAug 26, 2026Leak/Splash
It was reported that patient experienced high blood glucose and treated with bolus via pump on (b)(6) 2024 due to infusion set tubing was leaking at the site.
Patient problems: Hyperglycemia
MAUDE report 50446388 ↗InjuryAug 26, 2026Leak/Splash
It was reported that patient experienced high blood glucose and treated with bolus via pump on (b)(6) 2024 due to infusion set tubing was leaking at the site.
Patient problems: Hyperglycemia
MAUDE report 50446387 ↗InjuryAug 26, 2026Leak/Splash
It was reported that patient experienced high blood glucose and treated with bolus via pump on (b)(6) 2024 due to infusion set tubing was leaking at the site.
Patient problems: Hyperglycemia
MAUDE report 50446385 ↗InjuryAug 26, 2026Leak/Splash
It was reported that patient experienced high blood glucose and treated with bolus via pump on (b)(6) 2024 due to infusion set tubing was leaking at the site.
Patient problems: Hyperglycemia
MAUDE report 50446383 ↗MalfunctionAug 25, 2026Leak/Splash
Patient reported infusion set tubing was leaking at site event occurred on 21 Dec 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431031 ↗MalfunctionAug 25, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431001 ↗MalfunctionAug 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412698 ↗MalfunctionAug 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412570 ↗InjuryAug 21, 2026Leak/Splash
It was reported that the patient infusion set tubing was leaking at the site which leads to high blood glucose and treated with correction bolus via pump on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50362981 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280543 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280539 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280503 ↗MalfunctionAug 17, 2026Leak/Splash
It was reported that the patient experienced an infusion set tubing leakage at the site on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280491 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280473 ↗MalfunctionAug 17, 2026Leak/Splash
It was reported that the patient experienced an infusion set tubing leakage at the site on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280471 ↗
Other Set, Administration, Intravascular devices
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- 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.