Autosoft XCRecalls & reported problems across all models
Unomedical A/S · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31,720
- Deaths reported
- 2
- Injuries reported
- 6,215
- Recalls
- 0
We found 11 models of Autosoft XC by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 31,720 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Sep 30, 2026 — classified as 2 deaths, 6,215 injuries, 25,503 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (13,497 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Autosoft XC problems
Device problems
- Material Twisted/Bent13,497
- Loss of or Failure to Bond5,586
- Premature Separation3,581
- Leak/Splash2,956
- Detachment of Device or Device Component2,021
- Infusion or Flow Problem1,772
- Complete Blockage1,676
- Use of Incorrect Control/Treatment Settings1,043
Patient problems
- No Clinical Signs, Symptoms or Conditions16,024
- Hyperglycemia13,198
- Elevated Ketones/ Diabetic Ketoacidosis2,010
- Hemorrhage/Blood Loss/Bleeding232
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available103
- Skin Inflammation/ Irritation99
- Hypoglycemia83
- Pain78
Autosoft XC models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Autosoft XC 1001680Set, Administration, Intravascular1 death16,105 reports
- Autosoft XC 1001681Set, Administration, Intravascular1 death4,216 reports
- Autosoft XC 1006922Set, Administration, Intravascular3,990 reports
- Autosoft XC 1001683Set, Administration, Intravascular1,975 reports
- Autosoft XC 1010900Set, Administration, Intravascular1,395 reports
- Autosoft XC 1001728Set, Administration, Intravascular873 reports
- Autosoft XC 1001729Set, Administration, Intravascular849 reports
- Autosoft XC 1003912Set, Administration, Intravascular765 reports
- Autosoft XC 1010899Set, Administration, Intravascular616 reports
- Autosoft XC 1001682Set, Administration, Intravascular468 reports
- Autosoft XC 1009566Set, Administration, Intravascular468 reports
Recent Autosoft XC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced hyperglycemia caused by three separate bent cannula events at their abdomen insertion site, with each individual infusion set failing in less than 24 hours. Two of these events occurred within the span of a single month, during which the patient noticed symptoms within 3 hours of insertion for one set, and 3 or more hours after insertion for the other. The final bent cannula incident took place on 28-Aug-2026. All resulting high blood glucose (BG) episodes were managed and treated using correction injections via multiple daily injections (MDI).
Patient problems: Hyperglycemia
MAUDE report 50951256 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951085 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50951083 ↗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
It was reported that patient experienced an event on (b)(6) 2026 in which infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950115 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950112 ↗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
It was reported that the patient experienced recurrent occlusion alarms due to a blockage in the infusion set tubing on (b)(6)2026, resulting in hyperglycemia and was treated with correction insulin injection.
Patient problems: Hyperglycemia
MAUDE report 50949088 ↗InjurySep 30, 2026Complete Blockage
It was reported that the patient experienced recurring occlusion alarms associated with the infusion set identifying a blockage in the tubing, resulting high blood glucose and was treated with correction bolus via the pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948984 ↗InjurySep 30, 2026Complete Blockage
It was reported that the patient experienced occlusion alarms due to a blockage in the infusion set tubing, resulting in hyperglycemia and was treated with a correction insulin injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948981 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that the patient experienced an occlusion alarm (Alarm 2) caused by a blockage in the infusion set tubing on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948971 ↗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 ↗
Other Unomedical A/S products
- MiniMed Infusion Sets58 models · 30,240 reports
- Medtronic Extended27 models · 22,785 reports
- Autosoft9021 models · 20,579 reports · 1 recall
- Minimed Quick-set18 models · 16,559 reports
- MiniMed Mio Advance12 models · 11,094 reports
- TruSteel5 models · 4,387 reports
- Autosoft307 models · 3,945 reports
- inset13 models · 2,869 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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