Autosoft90™ 1002821Recalls & 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 Autosoft90 infusion set has 517 adverse event reports, with no deaths and 43 injuries. Many reports describe tubing that is bent or twisted, parts that do not stay bonded, sets falling off or separating during use, and leaks. Some describe high blood sugar or diabetic ketoacidosis, and others describe blocked tubing. 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
- 539
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 539 adverse event reports that list this exact device (DI 05705244018242), received between Feb 1, 2021 and Sep 29, 2026 — classified as 47 injuries, 492 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (266 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/Bent266
- Loss of or Failure to Bond128
- Premature Separation83
- Leak/Splash46
- Infusion or Flow Problem32
- Detachment of Device or Device Component30
- Device Handling Problem9
- Complete Blockage7
Patient problems
- No Clinical Signs, Symptoms or Conditions382
- Hyperglycemia104
- Elevated Ketones/ Diabetic Ketoacidosis32
- Hemorrhage/Blood Loss/Bleeding9
- Skin Inflammation/ Irritation7
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Nausea1
Recent adverse event reports
The 25 most recent of 539 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932096 ↗InjurySep 27, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909877 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885920 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that infusion set that fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885916 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885912 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885911 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885903 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set which was in use for one day fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863615 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set which was in use for one day fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863612 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set which was in use for one day fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863610 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set which was in use for one day fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863607 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set which was in use for one day fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863588 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834581 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834566 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834562 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619636 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619617 ↗MalfunctionSep 2, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557502 ↗MalfunctionAug 31, 2026Leak/Splash
It was reported that patient faced infusion set leakage event on (b)(6) 2025. The leakage was at the site. The infusion set was in use for two to three hours.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518046 ↗MalfunctionAug 27, 2026Premature Separation
It was reported that the patient experienced an infusion set falling off during use on (b)(6) 2026, the issue involved 10 infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482495 ↗MalfunctionAug 27, 2026Premature Separation
It was reported that the patient experienced an infusion set falling off during use on (b)(6) 2026, the issue involved 10 infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482486 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set fell during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480156 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set fell during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480019 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set fell during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480018 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Infusion set fell during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479997 ↗
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.