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Varisoft™ 1000287Recalls & 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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244014787), received between Apr 13, 2019 and Apr 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE TUBING OF ONE OF THE INFUSION SETS DISCONNECTED FROM THE PLASTIC PITCHFORK THAT ALLOWED FOR THE CONNECTION TO PATIENT'S SITE. AT THE TIME OF THIS EVENT, PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 178 MG/DL. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8511990 ↗

Other Set, Administration, Intravascular devices

All Set, Administration, Intravascular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.