Bard® InLay Optima® Ureteral Stent 788414Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741015649), received between Jun 2, 2021 and Jan 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING URETERAL STENT PLACEMENT, THE URETERAL STENT WAS OPENED AND THE BLADDER LOOP SUTURE REMOVED, REVEALING A FRACTURE AT THE SMALL HOLE OF THE BLADDER LOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173012 ↗
• MalfunctionNov 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, AFTER STONE SURGERY, UPON OPENING THE URETERAL STENT, FOREIGN MATTER WAS DISCOVERED IN THE SAC. REPLACED THE STENT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485359 ↗
• MalfunctionSep 25, 2025Flaked; Patient Device Interaction Problem; Flaked; Patient Device Interaction Problem

  IT WAS REPORTED THAT, THE URETERAL STENTS EXHIBIT A HIGH RATE OF SCABBING WHEN USED ON PATIENTS FOR APPROXIMATELY TWO WEEKS. WITHIN ONE MONTH, SCABBING HAD OCCURRED SEVEN OR EIGHT TIMES.

  Patient problems: Abrasion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23149382 ↗
• MalfunctionSep 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, WHEN USING THE URETERAL STENT, THE KIDNEY TRANSPLANT RECIPIENT REMOVED IT FROM THE PACKAGING, FIRST SNAPPED THE SUTURE THREAD, THEN STRAIGHTENED THE STENT, AND APPLIED A SIMPLE LATERAL PULL, CAUSING IT TO BREAK. AFTER REPLACING THE STENT, THE ISSUE DID NOT RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937280 ↗
• MalfunctionAug 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE KIDNEY TRANSPLANT PATIENT USES THE URETERAL STENT, THEY TAKE OUT THE PACKAGING BOX AND FIRST BREAK THE SILK THREAD, THEN STRAIGHTEN THE STENT AND GIVE IT A SIMPLE HORIZONTAL PULL, CAUSING IT TO BREAK. AND REPLACED THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913981 ↗
• MalfunctionJul 1, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN OPENED THE OUTER PACKAGING OF THE URETERAL STENT, IT WAS FOUND THAT THE INNER PACKAGING WAS DAMAGED, SO OPENED A NEW URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374348 ↗
• MalfunctionApr 3, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE STENT WAS UNABLE TO ADVANCE ON THE GUIDE WIRE. IT MAY BE A PROBLEM WITH AN EXCESSIVE RESISTANCE DURING STENT DELIVERY. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 19MAR2025, STATED THAT THEY TRIED ABOUT 3 TIMES TO ADVANCE THE STENT OVER THE GUIDEWIRE, BUT THEY FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762760 ↗
• MalfunctionAug 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE STONE SURGERY, THE PIGTAIL RING AT THE HEAD OF THE URETERAL STENT WAS FOUND TO BE BROKEN AFTER THE STENT PACKAGING WAS OPENED, SO IT WAS STOPPED FROM USE. REPLACED WITH A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20108373 ↗
• MalfunctionSep 12, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SEAL WAS FOUND DAMAGED UPON OPENING OF THE URETERAL STENT OUTER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728365 ↗
• MalfunctionNov 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAINAGE HOLE AT THE TIP OF THE URETERAL STENT WAS FOUND BROKEN AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781011 ↗
• MalfunctionJun 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT RIPPED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921926 ↗