Varisoft™ 1002827Recalls & 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 appears in 672 adverse event reports, with no deaths and 154 injuries. Reports mostly describe tubing that twisted or bent, parts coming apart, and leaks, with patients reporting high blood sugar. It has 1 open recall, started in October 2023, over a connector damaged in manufacturing that can detach more easily than intended. Reports rose over the last 12 months, to 307 from 135 in the 12 months before.
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
- 802
- Deaths reported
- 0
- Injuries reported
- 208
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 802 adverse event reports that list this exact device (DI 05705244018693), received between May 11, 2021 and Sep 30, 2026 — classified as 208 injuries, 594 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (204 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-0232-2024 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent204
- Loss of or Failure to Bond116
- Premature Separation105
- Detachment of Device or Device Component91
- Leak/Splash83
- Infusion or Flow Problem53
- Adverse Event Without Identified Device or Use Problem50
- Complete Blockage50
Patient problems
- No Clinical Signs, Symptoms or Conditions446
- Hyperglycemia318
- Elevated Ketones/ Diabetic Ketoacidosis18
- Abscess9
- Skin Infection8
- Hypoglycemia5
- Hemorrhage/Blood Loss/Bleeding4
- Skin Inflammation/ Irritation3
Recent adverse event reports
The 25 most recent of 802 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient two infusion set had high blood glucose 500 mg/dL (27.7 mmol/L and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50944127 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient two infusion set had high blood glucose 500 mg/dL (27.7 mmol/L and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50944060 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced four infusion sets fell off event on (b)(6) 2026 during use along with high blood glucose level of 400 mg/dL which was treated with correction injection via bolus and multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50936134 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced four infusion sets fell off event on (b)(6) 2026 during use along with high blood glucose level of 400 mg/dL which was treated with correction injection via bolus and multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50936132 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced four infusion sets fell off event on (b)(6) 2026 during use along with high blood glucose level of 400 mg/dL which was treated with correction injection via bolus and multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50936131 ↗InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced four infusion sets fell off event on 25 August 2026 during use along with high blood glucose level of 400 mg/dL which was treated with correction injection via bolus and multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50936129 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935077 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient stated the set fell off during use on (b)(6) 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929383 ↗MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909890 ↗InjurySep 27, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50909857 ↗InjurySep 26, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50907946 ↗InjurySep 26, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Hyperglycemia
MAUDE report 50907525 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907345 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50907318 ↗InjurySep 25, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an infusion set adhesive failure on (b)(6) 2026, where infusion set patch did not stick to skin upon insertion, this resulted in higher blood glucose levels and treated insulin via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50898134 ↗InjurySep 25, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced event where infusion set cannula was kinked resulting in high blood glucose (BG), which was treated with Correction bolus via pump use and an exact start date cannot be specified.
Patient problems: Hyperglycemia
MAUDE report 50896195 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
It was reported that the patient experienced infusion set site detached from applicator prior to insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895736 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient faced an event oaf Bent cannula which led to insulin flow blocked on (b)(6) 2026. Insertion site was abdomen. Patient faced same issue on two infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894772 ↗MalfunctionSep 25, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient faced an event oaf Bent cannula which led to insulin flow blocked on (b)(6)2026. Insertion site was abdomen. Patient faced same issue on two infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894730 ↗MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced that the infusion set tubing pulled off accidentally by getting caught on some object during use event on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894524 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose event and was treated via pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50893345 ↗MalfunctionSep 24, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885725 ↗MalfunctionSep 24, 2026Deformation Due to Compressive Stress
The patient reported that their infusion set tubing was broken on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882682 ↗MalfunctionSep 24, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881565 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the set fell off during use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879540 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.