inset™ FG000016-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05705244026254), received between Jan 11, 2025 and Sep 12, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Partial Blockage; Material Twisted/Bent

  Patient problems: Hyperglycemia

  MAUDE report 50745855 ↗
• MalfunctionAug 28, 2026Partial Blockage

  Patient problems: Hyperglycemia

  MAUDE report 50500600 ↗
• MalfunctionAug 20, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the patient experienced an infusion set being pulled off event causing the adhesive to be removed during use on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336064 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that patient used infusion set for 3 days which led to infection at the infusion set site which led to admission into Emergency Department with symptoms Headache, Skin Inflammation/ Irritation on (b)(6) 2026.

  Patient problems: Headache; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 50035349 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that patient used infusion set on their abdomen for approximately 6 days which led to infection at the infusion set site which led to admission into Emergency Department and performed an incision and drainage procedure to remove pus and blood from the site and provided iodine for wound care and was prescribed Doxycycline 100 mg on (b)(6) 2026.

  Patient problems: Skin Infection

  MAUDE report 50035346 ↗
• MalfunctionApr 18, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON 18 MAR 2026 WHERE PATIENT GRABBED TUBING WHILE IN BED AND INFUSION SITE FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919701 ↗
• MalfunctionApr 5, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT ACCIDENTALLY RIPPED OFF THE INFUSION SETS ON (B)(6) 2026 AFTER THE TUBING CAUGHT ON THE DOOR FRAMES CAUSING THE ADHESIVE TO BE REMOVED. THE EVENT OCCURRED WITH ABOUT EIGHT DIFFERENT SETS OVER THREE BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786692 ↗
• MalfunctionApr 5, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED THAT THE PATIENT ACCIDENTALLY RIPPED OFF THE INFUSION SETS ON 02-MAR-2026 AFTER THE TUBING CAUGHT ON THE DOOR FRAMES CAUSING THE ADHESIVE TO BE REMOVED. THE EVENT OCCURRED WITH ABOUT EIGHT DIFFERENT SETS OVER THREE BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786691 ↗
• MalfunctionApr 4, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH A BENT CANNULA. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 24784820 ↗
• MalfunctionNov 11, 2025Device Handling Problem; Device Handling Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT RE-USE OF SINGLE USE DEVICE ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 295 MG/DL NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 23520990 ↗
• InjuryMay 21, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED AN EVENT OF INFUSION SET BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE. ON (B)(6) 2025, PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE LEVELS WAS 285 MG/DL AND LASTED THREE HOURS. THE PATIENT FELT AWFUL AND DIAGNOSED WITH EUGENIC DKA AND LATER RECEIVED INTRAVENOUS DRIP AND GLUCAGON AS A CORRECTIVE TREATMENT IN THE HOSPITAL. THE TRACE KETONES WERE ALSO PRESENT. THE PATIENT RELEASED FROM THE HOSPITAL ON (B)(6) 2025. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22058621 ↗
• InjuryMar 21, 2025Material Twisted/Bent; Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED DIABETIC KETOACIDOSIS DUE TO BENT CANNULA EVENT WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED AND WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 386 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH MULTIPLE DAILY INJECTION (MDI). THE PATIENT WAS TESTED WITH KETONES AND THE RESULTS WERE HIGH. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 21662482 ↗
• MalfunctionJan 11, 2025Device Handling Problem; Device Handling Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 21132488 ↗