VarisoftRecalls & reported problems across all models

We found 8 models of Varisoft by Unomedical A/S in the FDA's device registry (GUDID). Together they are named in 1,250 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2019 and Sep 30, 2026 — classified as 284 injuries, 966 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (315 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Varisoft recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 23, 2024Open, Classified

   Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".

   Z-3186-2024 · Root cause: Process change control · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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.hyperglycemia). Diabetic ketoacidosis.

   Z-0233-2024 · Root cause: Process change control · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

Most reported Varisoft problems

Varisoft models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Varisoft™ 1002827

  Set, Administration, Intravascular
  1 recall802 reports
• Varisoft™ 1002828

  Set, Administration, Intravascular
  2 recalls172 reports
• Varisoft™ 1002830

  Set, Administration, Intravascular
  1 recall187 reports
• Varisoft™ 1002832

  Set, Administration, Intravascular
  81 reports
• Varisoft™ 1000284

  Set, Administration, Intravascular
  4 reports
• Varisoft™ 1000285

  Set, Administration, Intravascular
  2 reports
• Varisoft™ 1000286

  Set, Administration, Intravascular
  1 report
• Varisoft™ 1000287

  Set, Administration, Intravascular
  1 report

Recent Varisoft adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation

  Patient problems: Hyperglycemia

  MAUDE report 50931876 ↗
• InjurySep 29, 2026Loss of or Failure to Bond; Premature Separation

  It was reported that the patient faced 2 infusion sets falling off during use, leading to high blood glucose above 500 mg/dL, which was treated with a correction bolus via pump on (b)(6)2026.

  Patient problems: Hyperglycemia

  MAUDE report 50931848 ↗
• InjurySep 29, 2026Device Handling Problem

  Patient problems: Hyperglycemia

  MAUDE report 50929758 ↗
• 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 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient ended up hospitalized with diabetic ketoacidosis and pain on (b)(6)2026.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Pain

  MAUDE report 50928735 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient ended up hospitalized with diabetic ketoacidosis and pain on (b)(6) 2026.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Pain

  MAUDE report 50928636 ↗
• MalfunctionSep 27, 2026Use of Incorrect Control/Treatment Settings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50909890 ↗

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