Autosoft90™ 1002820Recalls & 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 is a single-use infusion set for delivering medicine under the skin. Its 551 reports mostly describe parts that fail to stay bonded, bent tubing, leaks and parts coming apart, and many list high blood sugar. The reports include no deaths and 71 injuries. Reports rose from 75 in the earlier 12 months to 238 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
- 628
- Deaths reported
- 0
- Injuries reported
- 107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 628 adverse event reports that list this exact device (DI 05705244018211), received between Jul 1, 2021 and Sep 27, 2026 — classified as 107 injuries, 521 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (180 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
- Loss of or Failure to Bond180
- Material Twisted/Bent131
- Leak/Splash113
- Premature Separation93
- Detachment of Device or Device Component67
- Fluid/Blood Leak33
- Infusion or Flow Problem33
- Complete Blockage29
Patient problems
- No Clinical Signs, Symptoms or Conditions311
- Hyperglycemia283
- Elevated Ketones/ Diabetic Ketoacidosis17
- Capsular Contracture5
- Hemorrhage/Blood Loss/Bleeding5
- Skin Infection4
- Blister2
- Cellulitis2
Recent adverse event reports
The 25 most recent of 628 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909888 ↗MalfunctionSep 26, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906843 ↗MalfunctionSep 26, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906837 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced that the infusion set was accidentally pulled out during use due to tubing catching on something or pump falling event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894507 ↗MalfunctionSep 23, 2026Leak/Splash
It was reported that the patient faced an event where infusion set tubing was leaking at the site on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870682 ↗MalfunctionSep 22, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced two infusion sets were accidentally pulled out during use event on 04 July 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850470 ↗MalfunctionSep 22, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced two infusion sets were accidentally pulled out during use event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850469 ↗MalfunctionSep 20, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834048 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50828368 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50828366 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50828361 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50828360 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828209 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blister; Skin Infection
MAUDE report 50828175 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828167 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828154 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828150 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828149 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828146 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50826126 ↗InjurySep 18, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50825314 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825284 ↗InjurySep 18, 2026Device Handling Problem
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50825269 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blister; Skin Infection
MAUDE report 50825266 ↗InjurySep 18, 2026Leak/Splash
Patient problems: Hyperglycemia
MAUDE report 50825150 ↗
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.