Autosoft90Recalls & reported problems across all models
Unomedical A/S · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20,579
- Deaths reported
- 2
- Injuries reported
- 3,620
- Recalls
- 1
We found 21 models of Autosoft90 by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 20,579 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2018 and Sep 30, 2026 — classified as 2 deaths, 3,620 injuries, 16,956 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (7,475 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Autosoft90 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 21, 2022Terminated
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Z-1810-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported Autosoft90 problems
Device problems
- Material Twisted/Bent7,475
- Loss of or Failure to Bond5,196
- Premature Separation3,957
- Leak/Splash1,810
- Detachment of Device or Device Component1,601
- Complete Blockage1,040
- Infusion or Flow Problem795
- Use of Incorrect Control/Treatment Settings668
Patient problems
- No Clinical Signs, Symptoms or Conditions12,891
- Hyperglycemia6,348
- Elevated Ketones/ Diabetic Ketoacidosis1,002
- Hemorrhage/Blood Loss/Bleeding160
- Hypoglycemia54
- Skin Inflammation/ Irritation54
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available39
- Pain37
Autosoft90 models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Autosoft90™ 1002817Set, Administration, Intravascular1 recall11,907 reports
- Autosoft90™ 1002819Set, Administration, Intravascular3,418 reports
- Autosoft90™ 1002823Set, Administration, Intravascular2 deaths1,489 reports
- Autosoft90™ 1000281Set, Administration, Intravascular969 reports
- Autosoft90™ 1002818Set, Administration, Intravascular683 reports
- Autosoft90™ 1002820Set, Administration, Intravascular628 reports
- Autosoft90™ 1002821Set, Administration, Intravascular539 reports
- Autosoft90™ 1002824Set, Administration, Intravascular361 reports
- Autosoft90™ 1000282Set, Administration, Intravascular359 reports
- Autosoft90™ 1002822Set, Administration, Intravascular100 reports
- Autosoft90™ 1000273Set, Administration, Intravascular52 reports
- Autosoft90™ 1000275Set, Administration, Intravascular24 reports
- Autosoft90™ 005908Set, Administration, Intravascular15 reports
- Autosoft90™ 005910Set, Administration, Intravascular12 reports
- Autosoft90™ 1000279Set, Administration, Intravascular7 reports
- Autosoft90™ 1000274Set, Administration, Intravascular4 reports
- Autosoft90™ 1000276Set, Administration, Intravascular4 reports
- Autosoft90™ 1000280Set, Administration, Intravascular4 reports
- Autosoft90™ 1000277Set, Administration, Intravascular2 reports
- Autosoft90™ 005912Set, Administration, Intravascular1 report
- Autosoft90™ 005913Set, Administration, Intravascular1 report
Recent Autosoft90 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where infusion set fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951057 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951050 ↗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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949583 ↗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
The patient reported that three infusion sets infusion set fell off during use on (b)(6)2026, (b)(6)2026, (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949291 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949288 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that three infusion sets infusion set fell off during use on (b)(6)2026, (b)(6)2026, (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949286 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949284 ↗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, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Correction bolus via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948600 ↗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 ↗
Other Unomedical A/S products
- Autosoft XC11 models · 31,720 reports
- MiniMed Infusion Sets58 models · 30,240 reports
- Medtronic Extended27 models · 22,785 reports
- 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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