inset™ FG000016-01Recalls & 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
Quick summary
This Unomedical inset infusion set is a single-use set for delivering fluid under the skin. Many reports describe twisted or bent tubing, blocked flow, and parts separating early, and many mention high blood sugar. The records include 1,919 reports, 412 injuries and no deaths, and no recalls name this device. Reports rose from 157 in the year before to 1,677 in the most recent year.
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
- 2,796
- Deaths reported
- 0
- Injuries reported
- 590
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,796 adverse event reports that list this exact device (DI 05705244025202), received between May 1, 2024 and Sep 30, 2026 — classified as 590 injuries, 2,206 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,307 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1,307
- Partial Blockage689
- Premature Separation523
- Loss of or Failure to Bond462
- Use of Incorrect Control/Treatment Settings343
- Complete Blockage239
- Leak/Splash138
- Fluid/Blood Leak115
Patient problems
- Hyperglycemia1,573
- No Clinical Signs, Symptoms or Conditions897
- Elevated Ketones/ Diabetic Ketoacidosis326
- Nausea100
- Polydipsia64
- Headache62
- Vomiting51
- Dry Mouth48
Recent adverse event reports
The 25 most recent of 2,796 reports, 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 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced set fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942312 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced set fell off due to poor adhesion of tape due to sweat on (b)(6) 2026 which led to high blood glucose, but no treatment was taken.
Patient problems: Hyperglycemia
MAUDE report 50942310 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced set fell off due to poor adhesion on (b)(6) 2026 which led to high blood glucose, but no treatment was taken.
Patient problems: Hyperglycemia
MAUDE report 50942301 ↗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 50942292 ↗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 50942290 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915017 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50915010 ↗InjurySep 28, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50914199 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that patient faced high blood glucose 230 mg/dl due to a site leaking event and no treatment mentioned on(b)(6)2026
Patient problems: Hyperglycemia
MAUDE report 50914181 ↗MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the infusion set came off the body shortly after insertion because the patient went into a pool on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912742 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.