Autosoft90™ 1002824Recalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Unomedical Autosoft90 infusion set is a single-use tube used to infuse medication under the skin. Its 329 reports describe tubing that twists or bends, leaks at the site, and parts that detach or separate, and some describe high blood sugar. The reports include no deaths and 48 injuries. 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
- 361
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 361 adverse event reports that list this exact device (DI 05705244018334), received between Oct 8, 2021 and Sep 29, 2026 — classified as 55 injuries, 306 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (149 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/Bent149
- Loss of or Failure to Bond57
- Leak/Splash52
- Detachment of Device or Device Component44
- Premature Separation42
- Infusion or Flow Problem19
- Adverse Event Without Identified Device or Use Problem14
- Fluid/Blood Leak10
Patient problems
- No Clinical Signs, Symptoms or Conditions179
- Hyperglycemia148
- Elevated Ketones/ Diabetic Ketoacidosis29
- Hemorrhage/Blood Loss/Bleeding7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Pain1
Recent adverse event reports
The 25 most recent of 361 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 50928722 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928718 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928603 ↗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 50864695 ↗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 50863681 ↗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 50863680 ↗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 50863678 ↗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 50863677 ↗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 50863675 ↗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 50863674 ↗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 50863656 ↗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 50863644 ↗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 50863643 ↗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 50863640 ↗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 50863639 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834586 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834585 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834584 ↗MalfunctionSep 20, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834583 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821167 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821158 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821154 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821149 ↗InjurySep 18, 2026Fluid/Blood Leak
It was reported that the patient faced an event with High Blood Glucose which they treated using bolus via pump and infusion set tubing was leaking at the site on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50821090 ↗MalfunctionSep 11, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced adhesive issues with infusion set because 6 sets fell off during usage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50726233 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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