Varisoft™ 1002828Recalls & 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
2 open recalls name 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 tube set for subcutaneous infusion, such as insulin. Its 141 reports often describe sets that detached or bent, and some describe high blood sugar after a set came loose. There are no deaths and 25 injuries. 2 recalls name this device, both open: one for sets packed in boxes with the wrong brand name, one for connectors that may detach too easily. Reports rose to 56 in the last 12 months from 25 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
- 172
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 05705244018723), received between May 24, 2021 and Sep 29, 2026 — classified as 41 injuries, 131 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (35 reports).
2 FDA recall records name this device's identifier, 2 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
- 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 · FDA record ↗
- 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 · FDA record ↗
Most reported problems
Device problems
- Material Twisted/Bent35
- Detachment of Device or Device Component31
- Loss of or Failure to Bond23
- Adverse Event Without Identified Device or Use Problem21
- Infusion or Flow Problem13
- Leak/Splash13
- Premature Separation13
- Loose or Intermittent Connection11
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- Hyperglycemia77
- Itching Sensation5
- Elevated Ketones/ Diabetic Ketoacidosis3
- Pain2
- Hemorrhage/Blood Loss/Bleeding1
- Skin Infection1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.
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 ↗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 18, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828269 ↗MalfunctionSep 18, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828265 ↗MalfunctionSep 18, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828258 ↗MalfunctionSep 18, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828249 ↗InjurySep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828060 ↗InjurySep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828051 ↗InjurySep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50828040 ↗InjurySep 18, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50825468 ↗MalfunctionSep 18, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825292 ↗MalfunctionSep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825026 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50821638 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50821506 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set fell off event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769304 ↗InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50745779 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50609622 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50609581 ↗MalfunctionSep 4, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607593 ↗MalfunctionSep 4, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607590 ↗MalfunctionSep 4, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607588 ↗MalfunctionSep 4, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607585 ↗
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- 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.