Bard® InLay Optima® Ureteral Stent 788614Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741015724), received between Aug 19, 2022 and Sep 25, 2024 — classified as 4 malfunctions.

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.

• MalfunctionSep 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KIDNEY TRANSPLANT IN THE OPERATING ROOM ON (B)(6) 2024. THE SURGEON PERFORMED ROUTINE OPERATIONS AND, UPON OPENING THE PACKAGE, FOUND THAT THE URETERAL STENT WAS BENT IN HALF AND COULD NOT BE USED, SO THEY REPLACED IT IMMEDIATELY. NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300819 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER THE CIRCULATING NURSE OPENED THE PACKAGE, THE HAND-WASHING NURSE TOOK THE STENT OUT OF THE PACKAGE. AFTER CUTTING THE TAIL THREAD AS INSTRUCTED BY THE DOCTOR, THEY FOUND THAT THE INDWELLING STENT WAS BENT IN ONE PLACE. AFTER THE CIRCULATING NURSE CONFIRMED THAT IT WAS UNUSABLE, THEY PUT IT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189625 ↗
• MalfunctionSep 30, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPIC SURGERY IN THE RIGHT SIDE AND NEEDED TO INDWELL A URETERAL STENT. THE NURSE DISASSEMBLED A ROOT AND FOUND THAT THE TUBE WAS RUPTURED. ANOTHER STENT WAS OPENED AND THAT WAS ALSO FOUND TO BE RUPTURED. IT WAS MENTIONED THAT EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 19AUG2022, IT WAS STATED THAT BOTH STENTS BELONGED TO THE SAME LOT AND THE EVENT INCLUDED EXTRA OPERATION OR DRUG THERAPY WAS REFERRING TO THE REPLACEMENT OF A NEW DEVICE. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 21SEP2022, IT WAS STATED THAT THE CUSTOMER RETURNED TWO URETERAL STENTS AND BOTH STENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519500 ↗
• MalfunctionAug 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPIC SURGERY IN THE RIGHT SIDE AND NEEDED TO INDWELL A URETERAL STENT. THE NURSE DISASSEMBLED A ROOT AND FOUND THAT THE TUBE WAS RUPTURED. ANOTHER STENT WAS OPENED AND THAT WAS ALSO FOUND TO BE RUPTURED. IT WAS MENTIONED THAT EXTRA OPERATION OR DRUG THERAPY WAS INCLUDED FOR THIS INCIDENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258773 ↗