Bard® InLay Optima® Ureteral Stent 788420Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741015656), received between Jun 25, 2021 and Sep 9, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Calcified1
- Material Fragmentation1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Calcium Deposits/Calcification1
- Hematuria1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Material Fragmentation
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50692465 ↗InjuryJun 28, 2021Calcified; Calcified
IT WAS REPORTED THAT DUE TO BILATERAL URETERAL STENOSIS, A URETERAL STENT WAS PLACED FOR DRAINAGE. DURING THE PLACEMENT OF THE URETERAL STENT, PATIENT EXPERIENCED INTERMITTENT GROSS HEMATURIA, WHICH WAS OBVIOUS AFTER THE ACTIVITY AND THE PATIENT RETURNED TO THE HOSPITAL AND WAS PULLED OUT THE BILATERAL URETERAL STENTS. DURING THE OPERATION, A LARGE NUMBER OF STONES WERE ATTACHED TO THE BLADDER SECTION OF THE DOUBLE J TUBE. THE BILATERAL URETERAL STENTS WERE TAKEN OUT UNDER DIRECT URETEROSCOPY. NO COMPLAINTS WERE COMPLAINED OF POSTOPERATIVE DISCOMFORT.
Patient problems: Calcium Deposits/Calcification
MAUDE report 12075167 ↗InjuryJun 25, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT DUE TO BILATERAL URETERAL STENOSIS, A URETERAL STENT WAS PLACED FOR DRAINAGE FOR THE PATIENT. DURING THE PLACEMENT OF THE URETERAL STENT, PATIENT EXPERIENCED INTERMITTENT GROSS HEMATURIA, WHICH WAS OBVIOUS AFTER THE ACTIVITY AND THE PATIENT RETURNED TO THE HOSPITAL AND WAS PULLED OUT THE BILATERAL URETERAL STENTS. DURING THE OPERATION, A LARGE NUMBER OF STONES WERE ATTACHED TO THE BLADDER SECTION OF THE DOUBLE J TUBE. THE BILATERAL URETERAL STENTS WERE TAKEN OUT UNDER DIRECT URETEROSCOPY. NO COMPLAINTS WERE COMPLAINED OF POSTOPERATIVE DISCOMFORT.
Patient problems: Hematuria
MAUDE report 12071775 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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