Autosoft90™ 1002819Recalls & 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 Autosoft90 infusion set from Unomedical is a single-use set for delivering fluid under the skin. Its 2,824 reports mostly describe the adhesive failing to hold, tubing bent or twisted, and sets coming loose or leaking. The reports include no deaths and 408 injuries, and high blood sugar and skin irritation are among the patient problems listed. Reports in the last 12 months (1,548) are well above the previous 12 months (511). 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
- 3,418
- Deaths reported
- 0
- Injuries reported
- 596
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,418 adverse event reports that list this exact device (DI 05705244018181), received between Apr 30, 2021 and Sep 30, 2026 — classified as 596 injuries, 2,822 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1,008 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 Bond1,008
- Material Twisted/Bent850
- Premature Separation840
- Leak/Splash341
- Detachment of Device or Device Component303
- Complete Blockage197
- Use of Incorrect Control/Treatment Settings195
- Infusion or Flow Problem168
Patient problems
- No Clinical Signs, Symptoms or Conditions2,247
- Hyperglycemia1,019
- Elevated Ketones/ Diabetic Ketoacidosis113
- Hemorrhage/Blood Loss/Bleeding34
- Skin Inflammation/ Irritation6
- Skin Infection5
- Unspecified Infection4
- Pain3
Recent adverse event reports
The 25 most recent of 3,418 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949953 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949948 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949710 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient's ten infusion sets fell off during use on (b)(6)2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949306 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949288 ↗InjurySep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced hyperglycemia associated with the kinked cannula events and was treated with correction bolus via the pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948737 ↗InjurySep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50948575 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was kinked which led to occlusion on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948340 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set used for three hours resulted in kinked cannula led to occlusion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947958 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leaking near the site on (b)(6)2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945454 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leaking near the site on (b)(6)-2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945451 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leaking near the site on (b)(6)2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945449 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leaking near the site on (b)(6) 2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945448 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set leaking near the site on (b)(6) 2026. The issue occurred with five infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945441 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944643 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944640 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944639 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient faced an issue where the infusion set was accidentally pulled out during use due to tubing catching on something or pump falling on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944636 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set fell off during use, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944116 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set fell off during use, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944022 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced accidental pull-out of the infusion set during use on (b)(6) 2026, due to the tubing catching on something or the pump falling over the past week.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943731 ↗MalfunctionSep 30, 2026Partial Blockage
It was reported that patient faced an event of infusion set delivery issue on (b)(6)2026. Insertion site was abdomen.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942848 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
It was reported that patient experienced disconnection difficulty on (b)(6) 2026 due to difficulty in disconnecting the infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942193 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936362 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936351 ↗
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.