VersaVue™ 5008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04719872715146), received between Jun 19, 2025 and Nov 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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

Recent adverse event reports

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

• MalfunctionNov 25, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING A RENAL STONE PROCEDURE USING A VERSAVUE SINGLE-USE DEVICE SCOPE, THE PHYSICIAN OBSERVED A TUMOR WHILE COMPLETING CYSTOSCOPY FOR WIRE PLACEMENT. THE PHYSICIAN INTRODUCED A BIOPSY FORCEPS; HOWEVER, WHEN THE FORCEPS WERE OPENED, THEY PENETRATED THROUGH THE SIDE OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT VERSAVUE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644976 ↗
• MalfunctionJun 19, 2025Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), A NON-BOSTON SCIENTIFIC SCOPE TO PLACE A WIRE FROM THE KIDNEY TO THE BLADDER, AND A VERSAVUE DEVICE WAS ALSO USED. WHEN ATTEMPTING TO REMOVE THE VERSAVUE, IT WAS NOTED THAT THE DEVICE BECAME STUCK IN THE SCOPE'S SHEATH AND BROKE APART. THE SHEATH WAS REMOVED, AND THE PROCEDURE HAD TO BE COMPLETED WITH AN ALTERNATIVE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290278 ↗