Autosoft30Recalls & reported problems across all models
Unomedical A/S · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,945
- Deaths reported
- 0
- Injuries reported
- 710
- Recalls
- 0
We found 7 models of Autosoft30 by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 3,945 adverse event reports in the FDA's MAUDE database, received between Dec 26, 2018 and Sep 30, 2026 — classified as 710 injuries, 3,235 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,217 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 Autosoft30 problems
Device problems
- Material Twisted/Bent1,217
- Loss of or Failure to Bond828
- Premature Separation581
- Leak/Splash435
- Detachment of Device or Device Component275
- Infusion or Flow Problem195
- Device Handling Problem182
- Fluid/Blood Leak146
Patient problems
- No Clinical Signs, Symptoms or Conditions2,322
- Hyperglycemia1,347
- Elevated Ketones/ Diabetic Ketoacidosis191
- Unspecified Infection45
- Hemorrhage/Blood Loss/Bleeding23
- Skin Infection14
- Skin Inflammation/ Irritation11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
Autosoft30 models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Autosoft30™ 1002825Set, Administration, Intravascular3,147 reports
- Autosoft30™ 1002826Set, Administration, Intravascular452 reports
- Autosoft30™ 1000283Set, Administration, Intravascular335 reports
- Autosoft30™ 1000200Set, Administration, Intravascular7 reports
- Autosoft30™ 007287Set, Administration, Intravascular2 reports
- Autosoft30™ 007288Set, Administration, Intravascular1 report
- Autosoft30™ 1000202Set, Administration, Intravascular1 report
Recent Autosoft30 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6) 2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949305 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6)2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949304 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6) 2026, (b)(6)2026, (b)(6) 2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949301 ↗MalfunctionSep 30, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949298 ↗MalfunctionSep 30, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949293 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient's six infusion set fell off during multiple physical activities events on (b)(6)2026, (b)(6)2026, (b)(6)2026 and (b)(6)2026 respectively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949281 ↗MalfunctionSep 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949091 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947621 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947620 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947487 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50947479 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50947477 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for two to three days resulted in bent cannula led to Hyperglycemia on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947476 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947077 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a kinked infusion set cannula on (b)(6)2026. The issue was noticed within 3 hours of insertion in the abdomen. As a result, the patient required a correction insulin injection via Multiple Daily Injections.
Patient problems: Hyperglycemia
MAUDE report 50945923 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- 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
- 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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