F88 0502388110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08881300750091), received between Nov 11, 2025 and Apr 17, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. 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.

• MalfunctionApr 17, 2026Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE SUBJECT DEVICE DID NOT PASS THE LEAK TEST, LEAK FAILURE WAS NEAR THE DISTAL TIP. DEVICE WAS USED ONCE IN A URETEROSCOPY (WITH LASER) PROCEDURE PRIOR TO FAILURE. THERE IS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24907288 ↗
• MalfunctionNov 11, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT DEVICE FAILED LEAK TEST DURING REPROCESSING. THERE WAS NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528886 ↗