Varisoft™ 1002832Recalls & 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 Varisoft infusion set is a single-use tubing set for delivering medicine under the skin. Many of the 82 reports describe the tubing twisting or bending and parts detaching or separating, and some mention high blood sugar in patients. The reports include 6 injuries and no deaths. No recalls name this device.
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
- 81
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05705244018846), received between May 18, 2021 and Sep 4, 2026 — classified as 7 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (30 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/Bent30
- Detachment of Device or Device Component16
- Loss of or Failure to Bond11
- Premature Separation11
- Infusion or Flow Problem8
- Device Handling Problem6
- Use of Incorrect Control/Treatment Settings4
- Material Perforation3
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Hyperglycemia30
- Nausea1
- Pain1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Device Handling Problem
It was reported that the patient experienced an infusion set misuse event that lead to high blood glucose and was treated via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50603569 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514275 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514274 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514273 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514272 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514271 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514270 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514269 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514262 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Detachment of Device or Device Component; Premature Separation
It was reported that adhesive patch detached from cannula housing/base prior to insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494772 ↗MalfunctionAug 25, 2026Leak/Splash
Patient reported infusion set tubing was leaking at site event occurred on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430611 ↗MalfunctionAug 13, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234322 ↗MalfunctionAug 13, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234293 ↗InjuryAug 9, 2026Device Handling Problem
It was reported that patient inserted infusion set into the scar tissue on abdomen on (b)(6) 2026. The patient experienced high blood glucose levels with associated nausea and moderate ketone levels.
Patient problems: Hyperglycemia; Nausea
MAUDE report 50188283 ↗MalfunctionAug 8, 2026Use of Incorrect Control/Treatment Settings
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 50186805 ↗MalfunctionApr 17, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THREE ADHESIVE ISSUES THAT THE PATIENT EXPERIENCED INFUSION SET WAS ACCIDENTALLY PULLED OUT DURING USE DUE TO TUBING CATCHING ON SOMETHING OR PUMP FALLING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907980 ↗MalfunctionApr 17, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THREE ADHESIVE ISSUES THAT THE PATIENT EXPERIENCED INFUSION SET WAS ACCIDENTALLY PULLED OUT DURING USE DUE TO TUBING CATCHING ON SOMETHING OR PUMP FALLING ON 19 MAR 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907979 ↗MalfunctionApr 17, 2026Use of Incorrect Control/Treatment Settings
IT WAS REPORTED THREE ADHESIVE ISSUES THAT THE PATIENT EXPERIENCED INFUSION SET WAS ACCIDENTALLY PULLED OUT DURING USE DUE TO TUBING CATCHING ON SOMETHING OR PUMP FALLING ON (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907958 ↗InjuryApr 10, 2026Device Handling Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 SINCE THE PATIENT USING COLD INSULIN AND GOT TREATED WITH CORRECTED VIA MULTIPLE DAILY INJECTIONS.
Patient problems: Hyperglycemia
MAUDE report 24839138 ↗InjuryApr 10, 2026Device Handling Problem
IT WAS REPORTED THAT PATIENT HAD EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026 SINCE THE PATIENT REMOVES AIR WITH EMPTY SYRINGE GOT TREATED WITH CORRECTED VIA MULTIPLE DAILY INJECTIONS.
Patient problems: Hyperglycemia
MAUDE report 24839136 ↗InjuryApr 1, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT PATIENT FACED OCCLUSION ALARM EVENT ON (B)(6) 2026. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND RECEIVED TREATMENT WITH CORRECTION BOLUS VIA PUMP.
Patient problems: Hyperglycemia
MAUDE report 24755474 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2026.THE PATIENT RECEIVED TREATMENT WITH CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 24754478 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SETS DETACHMENT ISSUES ON (B)(6) 2023 AS INFUSION SET TUBING DETACHED FROM HUB. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713782 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED THE INFUSION SET DETACHMENT EVENT ON (B)(6)2024. THE SITE OF DETACHMENT WAS TUBING CONNECTOR. THE INFUSION SET WAS IN USE FOR 14 HOURS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701409 ↗InjuryMar 22, 2026Device Handling Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIA EVENT ON (B)(6) 2026 DUE TO THE INFUSION SET BEING INSERTED INTO A BODY CREASE OR AN AREA SUBJECTED TO TEMPORARY POSITIONAL BLOCKAGE. THE BLOOD GLUCOSE LEVEL WAS HIGH AND TREATMENT GIVEN WAS A CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 24658156 ↗
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.