Varisoft™ 1002830Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Unomedical Varisoft infusion set is a single-use tubing set for subcutaneous insulin infusion. Of its 173 reports, 24 are filed as injuries, and many describe adhesive failures, detached parts, and kinked or bent tubing, while many mention high blood sugar. The reports mention no deaths. The set has 1 open recall, from October 2023, over connectors that can detach from the insulin set more easily than intended.
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
- 187
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 05705244018785), received between Mar 30, 2021 and Sep 30, 2026 — classified as 27 injuries, 160 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (46 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 11, 2023Open, Classified
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
Z-0234-2024 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent46
- Loss of or Failure to Bond38
- Detachment of Device or Device Component35
- Leak/Splash15
- Device Handling Problem14
- Infusion or Flow Problem13
- Premature Separation11
- Incomplete or Missing Packaging8
Patient problems
- No Clinical Signs, Symptoms or Conditions99
- Hyperglycemia76
- Elevated Ketones/ Diabetic Ketoacidosis7
- Skin Inflammation/ Irritation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
- Skin Infection1
Recent adverse event reports
The 25 most recent of 187 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing was leaking at the site on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945294 ↗MalfunctionSep 26, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908382 ↗MalfunctionSep 26, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908381 ↗MalfunctionSep 26, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908378 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828038 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827961 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827960 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827946 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827942 ↗MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825261 ↗MalfunctionSep 16, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient had experienced infusion set tape not sticking event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785727 ↗InjurySep 5, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50634027 ↗MalfunctionAug 14, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249154 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50247316 ↗InjuryAug 8, 2026Device Handling Problem
It was reported that the patient faced hyperglycemia treated with correction bolus via pump event on (b)(6)2026. Patient reported that the infusion set dislodged and leaking, not fully connected the infusion set to the site after taking a shower.
Patient problems: Hyperglycemia
MAUDE report 50185731 ↗MalfunctionAug 6, 2026Partial Blockage
It was reported that the Patient infusion set cannula got Kinked on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158671 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an infusion set adhesive failure on (b)(6) 2026, where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137534 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137527 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137526 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137522 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137488 ↗MalfunctionAug 3, 2026Partial Blockage; Material Twisted/Bent
The patient reported kinked cannula led to an occlusion which led to high blood glucose levels on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50109299 ↗InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem
Patient reported Infection HCP provide medication on (b)(6)2025 and there is no information related to product malfunction.
Patient problems: Skin Infection
MAUDE report 50101072 ↗InjuryJul 27, 2026Complete Blockage
It was reported that the patient experienced high blood glucose which was addressed by correction through pump due to Occlusion issue at the infusion set site on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50030989 ↗MalfunctionJul 11, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25789740 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.