Bard® InLay Optima® Multilength Ureteral Stent 788400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741015632), received between Dec 18, 2020 and May 10, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, URETERAL REFLUX, PAIN OR DISCOMFORT, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND OR BLADDER, INFECTION, AND URINARY SYMPTOMS PRIOR TO THE DEVICE PLACEMENT, AND PAIN OR DISCOMFORT COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND DECREASE IF BLADDER SIZE AND URINARY INCONTINENCE WAS NEEDED IN RELATION TO INLAY OPTIMA MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE, 4.7 FR, 22 -32CM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Incontinence; Pain

  MAUDE report 16901565 ↗
• MalfunctionNov 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA WHILE USING THE URETERAL STENT. IT WAS ALSO STATED THAT THE URETERAL STENT FRAGMENTED DURING USE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745942 ↗
• InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA WHILE USING THE URETERAL STENT. IT WAS ALSO STATED THAT THE URETERAL STENT FRAGMENTED DURING USE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR EDEMA.

  Patient problems: Swelling/ Edema

  MAUDE report 12745832 ↗
• InjuryDec 18, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT BROKE DURING REMOVAL ATTEMPT. THE PATIENT HAD THE URETERAL STENT PLACED AFTER LITHOTRIPSY ON (B)(6) 2020. REMOVAL WAS ATTEMPTED AT A CLINIC ON (B)(6) 2020. THE PATIENT HAD TO HAVE IT REMOVED AT THE HOSPITAL ON (B)(6) 2020. IT WAS "VERY MUCH CALICIFIED." THE PATHOLOGY REPORT NOTED: EXTERNAL SURFACE IS INSCRIBED WITH "BARD" AND "4.7F X 22-32 CM." MULTIPLE DEFECTS ARE IDENTIFIED EVERY 4 CM ALONG THE LENGTH, EACH LESS THAN 0.1 CM IN GREATEST DIMENSION. PER EMAIL RECEIVED FROM COMPLAINANT ON (B)(6) 2020, THE PATIENT HAD NO ADVERSE OUTCOME WITH REMOVAL OF THE RETAINED STENT PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11040060 ↗