ClosureRFS™ RFS2-6-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169862999), received between Feb 5, 2021 and Feb 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryFeb 5, 2021Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  PHYSICIAN WAS ATTEMPTING TO USE A CLOSURERFS ALONG WITH A GENERATOR DURING PROCEDURE TO TREAT A SEGMENT IN THE PERFORATOR VEINS. TUMESCENT INFILTRATION WAS UTILIZED. TRANSDUCER WAS USED FOR COMPRESSION. THE DEVICE WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. PROPER TEMPERATURE WAS REACHED. IT WAS REPORTED THAT MACHINE PROMPTED DEVICE BROKEN. PHYSICIAN CHANGED SURGICAL PLAN AND DEFERRED TO VEIN STRIPPING. THERE WAS NO FURTHER PATIENT INJURY. IT WAS ALSO NOTED THAT THE DEVICE WAS USED POST EXPIRATION DATE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11284306 ↗