Bard® InLay Optima® Ureteral Stent 788814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741015885), received between Sep 6, 2023 and Sep 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT WITH A TRANSPLANTED KIDNEY NEEDED PERCUTANEOUS STENTING OF THE URETER. DURING PLACEMENT, A CATHETER WAS USED TO PUSH THE STENT INTO PLACE IN THE URETER OVER A STIFF GUIDEWIRE. DESPITE THE STIFFNESS OF THE GUIDEWIRE, WHICH CANNOT BE STIFFER DUE TO VULNERABLE TISSUE IN THE KIDNEY, THE RADIOPAQUE TIP OF THE CATHETER BROKE AND MUST HAVE BEEN LEFT INSIDE THE RENAL PELVIS FOR FUTURE SURGICAL REMOVAL. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 18AUG2023, STATED THAT THE BROKEN OFF TIP OF THE PUSH CATHETER WAS EXTRACTED FROM THE KIDNEY SURGICALLY VIA PERCUTANEOUS NEPHROLITHOTOMY. THE EXTRACTED BROKEN OFF TIP WAS NOT STERILIZED, BUT IT WAS IN A SMALL CONTAINER. THERE WAS NO CYTOTOXIC MATERIAL, BUT IT MIGHT HAVE TRACES OF BLOOD. THE PATIENT IMPACT WAS THAT THE PATIENT HAD TO UNDERGO A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE IN GENERAL ANESTHESIA, WHERE THEY EXTRACTED THE BROKEN OFF TIP VIA A PERCUTANEOUS ACCESS INTO THE KIDNEY PELVIS. NO COMPLICATIONS HAPPENED DURING THIS PROCEDURE, BUT THERE WAS INHERENT RISK ASSOCIATED WITH IT. THERE WERE TWO OTHER OCCURRENCES OF TIPS BREAKING OFF AND THEY COULD BE EXTRACTED WITH CYSTOSCOPIC ACCESS THROUGH THE URETER

  Patient problems: Foreign Body In Patient

  MAUDE report 17836076 ↗
• InjurySep 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT WITH A TRANSPLANTED KIDNEY NEEDED PERCUTANEOUS STENTING OF THE URETER. DURING PLACEMENT, A CATHETER WAS USED TO PUSH THE STENT INTO PLACE IN THE URETER OVER A STIFF GUIDEWIRE. DESPITE THE STIFFNESS OF THE GUIDEWIRE, WHICH CANNOT BE STIFFER DUE TO VULNERABLE TISSUE IN THE KIDNEY, THE RADIOPAQUE TIP OF THE CATHETER BROKE AND MUST HAVE BEEN LEFT INSIDE THE RENAL PELVIS FOR FUTURE SURGICAL REMOVAL. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 18AUG2023, STATED THAT THE BROKEN OFF TIP OF THE PUSH CATHETER WAS EXTRACTED FROM THE KIDNEY SURGICALLY VIA PERCUTANEOUS NEPHROLITHOTOMY. THE EXTRACTED BROKEN OFF TIP WAS NOT STERILIZED, BUT IT WAS IN A SMALL CONTAINER. THERE WAS NO CYTOTOXIC MATERIAL, BUT IT MIGHT HAVE TRACES OF BLOOD. THE PATIENT IMPACT WAS THAT THE PATIENT HAD TO UNDERGO A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE IN GENERAL ANESTHESIA, WHERE THEY EXTRACTED THE BROKEN OFF TIP VIA A PERCUTANEOUS ACCESS INTO THE KIDNEY PELVIS. NO COMPLICATIONS HAPPENED DURING THIS PROCEDURE, BUT THERE WAS INHERENT RISK ASSOCIATED WITH IT. THERE WERE TWO OTHER OCCURRENCES OF TIPS BREAKING OFF AND THEY COULD BE EXTRACTED WITH CYSTOSCOPIC ACCESS THROUGH THE URETER

  Patient problems: Foreign Body In Patient

  MAUDE report 17823876 ↗
• InjurySep 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT WITH A TRANSPLANTED KIDNEY NEEDED PERCUTANEOUS STENTING OF THE URETER. DURING PLACEMENT, A CATHETER WAS USED TO PUSH THE STENT INTO PLACE IN THE URETER OVER A STIFF GUIDEWIRE. DESPITE THE STIFFNESS OF THE GUIDEWIRE, WHICH CANNOT BE STIFFER DUE TO VULNERABLE TISSUE IN THE KIDNEY, THE RADIOPAQUE TIP OF THE CATHETER BROKE AND MUST HAVE BEEN LEFT INSIDE THE RENAL PELVIS FOR FUTURE SURGICAL REMOVAL. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 18AUG2023, STATED THAT THE BROKEN OFF TIP OF THE PUSH CATHETER WAS EXTRACTED FROM THE KIDNEY SURGICALLY VIA PERCUTANEOUS NEPHROLITHOTOMY. THE EXTRACTED BROKEN OFF TIP WAS NOT STERILIZED, BUT IT WAS IN A SMALL CONTAINER. THERE WAS NO CYTOTOXIC MATERIAL, BUT IT MIGHT HAVE TRACES OF BLOOD. THE PATIENT IMPACT WAS THAT THE PATIENT HAD TO UNDERGO A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE IN GENERAL ANESTHESIA, WHERE THEY EXTRACTED THE BROKEN OFF TIP VIA A PERCUTANEOUS ACCESS INTO THE KIDNEY PELVIS. NO COMPLICATIONS HAPPENED DURING THIS PROCEDURE, BUT THERE WAS INHERENT RISK ASSOCIATED WITH IT. THERE WERE TWO OTHER OCCURRENCES OF TIPS BREAKING OFF AND THEY COULD BE EXTRACTED WITH CYSTOSCOPIC ACCESS THROUGH THE URETER

  Patient problems: Foreign Body In Patient

  MAUDE report 17690280 ↗