iLet Flex FG000063-04Recalls & reported problems
Unomedical A/S · ilet Flex, 6mm, 60cm 10 pack · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05705244026902), received between Aug 13, 2026 and Sep 30, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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
- Loss of or Failure to Bond12
- Premature Separation12
- Use of Incorrect Control/Treatment Settings11
- Material Twisted/Bent5
- Partial Blockage4
- Adverse Event Without Identified Device or Use Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Hyperglycemia10
- Diaphoresis1
- Elevated Ketones/ Diabetic Ketoacidosis1
- Fatigue1
Recent adverse event reports
The 25 most recent of 30 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, as the infusion set tape did not adhere properly upon insertion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944099 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced infusion set sticky adhesive is falling off their body, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943801 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced his infusion set started to come off because he is working in the heat, event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943798 ↗MalfunctionSep 29, 2026Use of Incorrect Control/Treatment Settings
It was reported that the infusion set required replacement because the tubing became detached from the patient's body while the connector remained intact in the pump on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929057 ↗MalfunctionSep 28, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient stated the accidentally yanked their set off their body on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912280 ↗MalfunctionSep 28, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient stated the accidentally yanked their set on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912277 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose of 380 mg/dL along with large ketone values event with symptoms of fatigue on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Fatigue; Hyperglycemia
MAUDE report 50912091 ↗MalfunctionSep 27, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909722 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the cannula was bent on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894097 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced pump fell off and pulled out his site while they were working because of tubing got caught led to adhesion removal out event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878605 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced infusion set got caught and was pulled off while taking of shirt led removal of adhesion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878600 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced infusion set was accidentally yanked and detached from their abdomen when their pump bag was moved led to poor adhesion event on 22 Aug 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878596 ↗MalfunctionSep 24, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced infusion set ripped out led to adhesion removal event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878584 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient reported that infusion site came off as patient accidentally got tubing caught which removed site from body on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877705 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient reported that their site fell off due to sweating on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877704 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
The patient reported that the infusion set is coming off after taking shower which lead to hyperglycaemia and diaphoresis on (b)(6) 2026.
Patient problems: Diaphoresis; Hyperglycemia
MAUDE report 50877701 ↗MalfunctionSep 21, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838965 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50838873 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838867 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on (b)(6) 2026 where infusion set fell off due to poor adhesion which led to high blood glucose.
Patient problems: Hyperglycemia
MAUDE report 50838866 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50838859 ↗MalfunctionSep 21, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient had high blood glucose due to that cannula got bent and with no treatment on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50837911 ↗MalfunctionSep 21, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50837898 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had loosened and repositioned the infusion set after insertion, likely contributing to the bent cannula and also experinced hyperglycemia while using the infusion set on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50836846 ↗MalfunctionSep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50822628 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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