Autosoft90™ 1002823Recalls & 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 set for subcutaneous infusion. Many of the 1,340 reports describe tubing twisting or bending, parts failing to bond, or leaks, and some describe the set being pulled out or falling during use. Hyperglycemia is listed as a patient problem in 436 reports. The reports include 2 deaths, 122 injuries and 1,216 malfunctions. 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
- 1,489
- Deaths reported
- 2
- Injuries reported
- 133
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,489 adverse event reports that list this exact device (DI 05705244018303), received between Nov 18, 2021 and Sep 29, 2026 — classified as 2 deaths, 133 injuries, 1,354 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (673 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/Bent673
- Loss of or Failure to Bond449
- Premature Separation264
- Leak/Splash125
- Detachment of Device or Device Component69
- Infusion or Flow Problem49
- Fluid/Blood Leak27
- Material Deformation24
Patient problems
- No Clinical Signs, Symptoms or Conditions897
- Hyperglycemia447
- Elevated Ketones/ Diabetic Ketoacidosis85
- Hemorrhage/Blood Loss/Bleeding32
- Hypoglycemia25
- Skin Inflammation/ Irritation8
- Bacterial Infection5
- Pain2
Recent adverse event reports
The 25 most recent of 1,489 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 50931242 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931237 ↗InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50928709 ↗InjurySep 26, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50907300 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an infusion set fell off event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881388 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set used for few hours fell off on(b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863742 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863741 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863705 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863704 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced an event where the infusion set used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863703 ↗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 used for few hours fell off on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863702 ↗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 used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863696 ↗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 used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863638 ↗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 50863637 ↗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 50863636 ↗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 used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863635 ↗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 50863634 ↗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 used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863632 ↗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 used for few hours fell off on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863631 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834631 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834624 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834622 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834621 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834620 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834612 ↗
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 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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