Autosoft90™ 1000281Recalls & 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
All models of Autosoft90 (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical Autosoft90 infusion set is a single-use tube set that delivers medicine under the skin. The 930 reports mostly describe tubing that is twisted or bent, adhesive that fails to stick, sets coming loose, and leaks. Many mention high blood sugar, and some mention ketone build-up. The reports include no deaths and 100 injuries, and no recalls name this device. Reports fell to 106 over the last year from 203 in the year before.
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
- 969
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 969 adverse event reports that list this exact device (DI 05705244014541), received between Jan 21, 2019 and Sep 29, 2026 — classified as 119 injuries, 850 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (443 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent443
- Loss of or Failure to Bond168
- Detachment of Device or Device Component133
- Leak/Splash102
- Infusion or Flow Problem43
- Premature Separation34
- Fluid/Blood Leak17
- Complete Blockage15
Patient problems
- No Clinical Signs, Symptoms or Conditions495
- Hyperglycemia399
- Elevated Ketones/ Diabetic Ketoacidosis65
- No Known Impact Or Consequence To Patient4
- Hypoglycemia3
- Hemorrhage/Blood Loss/Bleeding2
- Pain2
Recent adverse event reports
The 25 most recent of 969 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932462 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932458 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931551 ↗InjurySep 27, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909847 ↗InjurySep 27, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909793 ↗InjurySep 27, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909770 ↗InjurySep 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50909739 ↗MalfunctionSep 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881939 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the patient experienced infusion set tubing was leaking at the site Event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881843 ↗MalfunctionSep 24, 2026Leak/Splash
It was reported that the patient experienced infusion set tubing was leaking at the site Event on (b)(6)2026, (b)(6)2026 and (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881835 ↗MalfunctionSep 24, 2026Partial Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880469 ↗MalfunctionSep 24, 2026Partial Blockage
It was reported that the patient experienced recurring occlusion issues, and troubleshooting indicated a problem with the infusion set site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880043 ↗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 faced same issue in four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864072 ↗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 faced same issue in four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864071 ↗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 faced same issue in four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864064 ↗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 faced same issue in four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864002 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape not sticking event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785725 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50784523 ↗MalfunctionSep 13, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747682 ↗MalfunctionSep 11, 2026Complete Blockage
It was reported that the patient experienced an event of blockage located in the tubing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726750 ↗MalfunctionSep 8, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50666146 ↗MalfunctionSep 5, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50631146 ↗MalfunctionSep 5, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50629929 ↗MalfunctionSep 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50628640 ↗InjurySep 4, 2026Leak/Splash
It was reported that patient experienced hyperglycemia which was treated with correction via Multiple daily injections due to infusion set tubing leaking at site on (b)(6) 2024.
Patient problems: Hyperglycemia
MAUDE report 50615457 ↗
Other Set, Administration, Intravascular devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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