Varisoft™ 1000285Recalls & 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
All models of Varisoft (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244014725), received between Jan 25, 2019 and Apr 5, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET TUBING HAD DETACHED FROM THE CANNULA HOUSING. THE BLOOD GLUCOSE LEVEL WAS 170 MG/DL AND HE DID NOTICED DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8486255 ↗MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HER INFUSION SET TUBING BROKE FROM WHERE IT IS ATTACHED TO THE SITE CONNECTER. IT APPEARED THAT THE ADHESIVE THAT CONNECTS THE TUBING TO THE SITE FAILED. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 198 MG/DL AT THE TIME OF THE EVENT. THE INFUSION SET TUBING WAS NOT PULLED. SHE CHANGED THE INFUSION SET TUBING TO RESOLVE THE ISSUE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8276827 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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