Autosoft XC 1006922Recalls & 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 Autosoft XC (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Autosoft XC infusion set is a single-use tube set for infusion under the skin. Its 2,929 adverse event reports often describe the tubing being twisted or bent, parts coming apart or detaching, and blockages. Some reports describe high blood sugar after the set fell off or its cannula bent. The reports include no deaths and 564 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
- 3,990
- Deaths reported
- 0
- Injuries reported
- 966
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,990 adverse event reports that list this exact device (DI 05705244022386), received between May 6, 2024 and Sep 30, 2026 — classified as 966 injuries, 3,024 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,723 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/Bent1,723
- Loss of or Failure to Bond690
- Premature Separation658
- Complete Blockage343
- Detachment of Device or Device Component219
- Infusion or Flow Problem205
- Device Handling Problem203
- Leak/Splash190
Patient problems
- No Clinical Signs, Symptoms or Conditions2,127
- Hyperglycemia1,613
- Elevated Ketones/ Diabetic Ketoacidosis223
- Hemorrhage/Blood Loss/Bleeding20
- Skin Inflammation/ Irritation19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Pain7
- Unspecified Infection6
Recent adverse event reports
The 25 most recent of 3,990 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 50951085 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an event where an Infusion set came off on (b)(6)2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50951063 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949727 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949708 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948745 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948740 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948739 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948735 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948606 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient had experienced Infusion set cannula was kinked which led to occlusion at site on 3(b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948586 ↗InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced Infusion set insulin flow blocked causing high blood glucose levels and treated with insulin pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946888 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient experienced Infusion set adhesive patch and cannula housing detached from spring prior to insertion event on 31 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946873 ↗InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced Three events in which infusion set fell off during use resulting in High Blood Glucose level treated with Correction injection via Multiple Daily Injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946502 ↗InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50946383 ↗InjurySep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50946379 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where two infusion set patch was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945335 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where two infusion set patch was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945299 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set patch was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944347 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set adhesive failure on (b)(6) 2026, as the infusion set tape did not adhere properly upon insertion. The event involved four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944242 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set adhesive failure on 01 Sep 2026, as the infusion set tape did not adhere properly upon insertion. The event involved four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944240 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set adhesive failure on (b)(6)2026, as the infusion set tape did not adhere properly upon insertion. The event involved four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944230 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient faced an event where adhesive patch and cannula housing detached from spring prior to insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944155 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient faced an event where adhesive patch and cannula housing detached from spring prior to insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944147 ↗MalfunctionSep 30, 2026Premature 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 50944128 ↗MalfunctionSep 30, 2026Premature 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 50944123 ↗
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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