VARIAX 45-85000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540540546), received between Sep 15, 2015 and Jun 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "AFTER THE OPERATION, IN-HOSPITAL CLEANER NOTICED THAT THE SCREW OF THE REVOLVING/RIGID SWITCHING PART OF THE SCREWDRIVER HANDLE WAS MISSING AFTER RUNNING WATER RINSING AND ULTRASONIC CLEANING. IT IS UNCLEAR AT WHAT POINT IN TIME THE SCREW WAS MISSING. HOWEVER, WHEN THE SALES REP ASKED THE SURGEON AND ASSISTANT, THEY SAID THAT THEY WOULD NOTICE IF THE SCREW FELL OFF DURING THE SURGERY. THUS, THE FACILITY CONCLUDED THAT THE SCREW WAS PROBABLY FALLEN OFF AND WAS DOWN TO THE SINK DURING RUNNING WATER RINSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218746 ↗
• MalfunctionSep 15, 2015Break

  SCREW DRIVER HANDLE WAS FOUND IN TRAY, BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5079261 ↗