Bard® InLay Optima® Ureteral Stent 788624Recalls & 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
Quick summary
This Bard Inlay Optima ureteral stent is a soft plastic tube placed in the ureter to keep it open. Most of the 38 reports describe the stent arriving damaged — cracked, torn, cut, or broken, sometimes only noticed when the package was opened — with a few mentioning calcification and pain; 5 reports involved injuries and no deaths were reported. There are no recalls naming this device. Reports dropped sharply, from 11 in the prior 12 months to 1 in the past12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741015755), received between Dec 20, 2017 and Dec 5, 2025 — classified as 5 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (15 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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation15
- Patient Device Interaction Problem4
- Biocompatibility3
- Calcified3
- Fracture3
- Material Split, Cut or Torn3
- Component Missing2
- Material Too Rigid or Stiff2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Pain2
- Unspecified Infection2
- Discomfort1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
IT WAS REPORTED THAT UPON OPENING THE STENT WAS DAMAGED. PER ADDITIONAL INFORMATION RECEIVED ON 04DEC2025, THERE WAS A SCRATCH NEAR THE LUMEN, AND IT LOOKED LIKE IT MIGHT TEAR AND ALSO, THEY NOTICED DAMAGE TO THE DEVICE UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735152 ↗MalfunctionSep 17, 2025Component Missing; Missing Information; Component Missing; Missing Information
IT WAS REPORTED THAT NO STICKER SEAL WAS ATTACHED WITHOUT A GUTTER. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 24SEP2025, STATED THAT "NO DRAIN" STICKER WAS NOT ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076137 ↗MalfunctionAug 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT BEFORE USE THE DOUBLE J SEGMENT OF THE URETERAL STENT WAS DAMAGED, IT WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22883269 ↗MalfunctionJul 31, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT THE PROTECTION CAP OF THE URETERAL STENT HAD BEEN BROKEN AND THE STRING OF STENT GOT STUCK IN THE CAP BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676010 ↗MalfunctionJul 31, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, THE PROTECTION CAP OF THE URETERAL STENT HAD BEEN BROKEN AND THE STRING OF STENT GOT STUCK IN THE CAP BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676009 ↗MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TAIL OF THE URETERAL STENT HAD BEEN DAMAGED WHEN OPENING THE PACKAGING OF INLAY OPTIMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329807 ↗MalfunctionJun 24, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING USE IT WAS DISCOVERED THAT THE TIP OF THE STENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320023 ↗MalfunctionJun 12, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TAIL OF URETERAL STENT HAD ALREADY BEEN CUT OFF WHEN THEY OPENED THE PACKAGE OF INLAY OPTIMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195615 ↗MalfunctionJun 4, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN THEY OPENED THE STENT, THE TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140761 ↗InjuryMar 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE NEPHROSTOMY SURGERY, THE SURFACE OF THE TIP, END POINT OF THE GUIDEWIRE WAS SHAVED OFF AND LEFT BEHIND IN THE BODY WHEN USED IN COMBINATION WITH A METAL NEEDLE.
Patient problems: Foreign Body In Patient
MAUDE report 21547855 ↗MalfunctionDec 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff
IT WAS REPORTED THAT URETERAL CATHETER ADAPTER WAS HARD. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07DEC2024, CUSTOMER CONFIRMED THAT PATIENT INVOLVED BUT NO INJURY. AND 3 PRODUCTS WERE AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000088 ↗MalfunctionNov 27, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE INLAY OPTIMA URETERAL STENT, SPECIALLY ONE OF THE STRING J SIDE OF THE STENT WAS SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795907 ↗MalfunctionOct 8, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AFTER OPENING THE PRODUCT, SHAPE OF THE PIGTAIL OPTIMUS STENT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397251 ↗MalfunctionAug 2, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING USE, WHEN THE USER TRIED TO INSERT THE URETERAL STENT, IT WAS BENT AND THE GUIDEWIRE COULD NOT PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19892533 ↗MalfunctionNov 16, 2023Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE FACTORY FAULT FOR THE STENT BEING BLOCKED. THEY STATED IT WAS A FACTORY FAULT AND SOMEHOW THE STENT WAS BLOCKED. IT WAS STATED THAT MORE INFORMATION WAS REQUIRED FROM THE DOCTOR. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 01NOV2023, THE EVENT HAPPENED ON THE 23RD OF OCTOBER 2023. THE STENT COULD NOT FEED INTO THE GUIDEWIRE. IT WAS THE BARD NITINOL GUIDEWIRE AND THE STENT COULD NOT FEED OVER IT, AS IF IT WAS STUCK. IT WAS A ONCE OFF EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150487 ↗MalfunctionNov 8, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TAIL OF URETERAL STENT WAS CUT OFF WHILE OPENING THE PACKAGE OF URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18093599 ↗MalfunctionNov 7, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN THE URETERAL STENT WAS RELEASED, ONE OF THEM CAME OUT BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18084154 ↗MalfunctionAug 9, 2023Component Missing; Component Missing
IT WAS REPORTED THAT PUSHER WAS NOT INCLUDED IN THE PACKAGE WHEN THE USER OPENED THE PACKAGE OF INLAY OPTIMA URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17490570 ↗InjuryMay 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THEY EXPERIENCED URINARY SYMPTOMS AND HEMATURIA PRIOR TO THE DEVICE PLACEMENT, AND URINARY SYMPTOMS, HEMATURIA COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TABLETS WERE NEEDED FOR URINARY SYMPTOMS IN RELATION TO INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 6 FR. X 24CM.
Patient problems: Hematuria; Unspecified Kidney or Urinary Problem
MAUDE report 16940038 ↗MalfunctionApr 6, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT FRONT END OF THE URETERAL STENT WAS FOUND TO BE FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16689971 ↗MalfunctionMar 12, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGE OF URETERAL STENT WAS FOUND TO BE NOT SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16527265 ↗MalfunctionJul 11, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER OPENED THE PACKAGE, THE URETERAL STENT BROKE AS THE COIL SEPARATED WITH THE STRAIGHT SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14978096 ↗MalfunctionJun 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT PLASTIC PACKAGE OF URETERAL STENT WAS FOUND TO BE BROKEN UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14836527 ↗MalfunctionMar 4, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE REMOVAL OF THE BLACK WIRE RESULTED IN TUBE BREAKAGE OF THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666230 ↗MalfunctionNov 22, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRONT TIP OF URETERAL STENT WAS FOUND TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12856032 ↗
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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