insetRecalls & reported problems across all models
Unomedical A/S · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,869
- Deaths reported
- 0
- Injuries reported
- 637
- Recalls
- 0
We found 13 models of inset by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 2,869 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2018 and Sep 30, 2026 — classified as 637 injuries, 2,232 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,348 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 inset problems
Device problems
- Material Twisted/Bent1,348
- Partial Blockage691
- Premature Separation523
- Loss of or Failure to Bond463
- Use of Incorrect Control/Treatment Settings347
- Complete Blockage239
- Leak/Splash138
- Fluid/Blood Leak115
Patient problems
- Hyperglycemia1,583
- No Clinical Signs, Symptoms or Conditions901
- Elevated Ketones/ Diabetic Ketoacidosis374
- Nausea100
- Polydipsia64
- Headache63
- Vomiting51
- Dry Mouth48
inset models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- inset™ FG000016-01Set, Administration, Intravascular2,796 reports
- inset™ 100-182-00Set, Administration, Intravascular30 reports
- inset™ 100-181-00Set, Administration, Intravascular16 reports
- inset™ FG000016-05Set, Administration, Intravascular13 reports
- inset™ 100-182-02Set, Administration, Intravascular4 reports
- inset™ 100-182-01Set, Administration, Intravascular2 reports
- inset™ 100-181-02Set, Administration, Intravascular2 reports
- inset™ 100-361-14Set, Administration, Intravascular1 report
- inset™ 100-182-03Set, Administration, Intravascular1 report
- inset™ 100-181-03Set, Administration, Intravascular1 report
- inset™ 100-183-00Set, Administration, Intravascular1 report
- inset™ 005758Set, Administration, Intravascular1 report
- inset™ 005760Set, Administration, Intravascular1 report
Recent inset 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 the patient experienced an infusion set adhesive failure on (b)(6) 2026 where the infusion set tape was not adhered up on insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944114 ↗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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944113 ↗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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944112 ↗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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944110 ↗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 and fell off immediately.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944106 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced sweating his infusion sets off, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943878 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced sweating his infusion sets off, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943768 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion site came off body, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943767 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set come off, event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50943766 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set came off, event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943760 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set came off body, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943752 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set adhesive keeps falling off their body, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943746 ↗MalfunctionSep 30, 2026Premature Separation
It was reported that the patient experienced poor adhesive performance due to sweating while working outside on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942319 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced site fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942318 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient's infusion set fell off after awaking on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942313 ↗
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
- Autosoft307 models · 3,945 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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