Bard InLay Optima Ureteral Stent with NiCore GuidewireRecalls & reported problems across all models
C. R. Bard, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 8 models of Bard InLay Optima Ureteral Stent with NiCore Guidewire by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2017 and Aug 3, 2026 — classified as 14 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bard InLay Optima Ureteral Stent with NiCore Guidewire problems
Device problems
- Material Fragmentation27
- Calcified17
- Wrong Label14
- Biocompatibility7
- Inadequate Instructions for Healthcare Professional5
- Patient Device Interaction Problem5
- Component Missing4
- Difficult to Insert3
Patient problems
- No Clinical Signs, Symptoms or Conditions61
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Pain8
- Hematuria6
- Micturition Urgency4
- Exposure to Body Fluids3
- Calcium Deposits/Calcification2
- Discomfort2
Bard InLay Optima Ureteral Stent with NiCore Guidewire models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 36 reports
- 21 reports
- 12 reports
- 6 reports
- 3 reports
- 1 report
- 1 report
- 1 report
Recent Bard InLay Optima Ureteral Stent with NiCore Guidewire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Calcified
It was reported that during use patient had the stent in place for less than two months when severe calculus buildup was discovered; the stent was removed endoscopically.
Patient problems: Calcium Deposits/Calcification; Exposure to Body Fluids
MAUDE report 50124265 ↗MalfunctionJun 16, 2026Calcified
It was reported that the patient had the Ureteral stent in place for less than two months, and severe stone encrustation was found, so the stent was removed and a new stent was implanted. The user was exposed to hazardous substances, blood, or body fluids.
Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions
MAUDE report 25521767 ↗MalfunctionMay 7, 2026Calcified; Material Fragmentation
IT WAS REPORTED THAT THE STENT WAS LEFT IN PLACE FOR TWO MONTHS AND BECAME COMPLETELY ENCRUSTED WITH CALCULI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113489 ↗MalfunctionApr 11, 2026Inadequacy of Device Shape and/or Size
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE/SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "MARKED OBSTRUCTION", REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM. ALSO STATED THAT "NO THE GUIDEWIRE DID NOT SUPPORT STENT PLACEMENT PROCEDURE" BECAUSE "OVERLY NARROW URETERS". REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24850171 ↗InjuryApr 8, 2026Calcified
IT WAS REPORTED THAT THE URETERAL STENT HAD BEEN IN PLACE FOR OVER A MONTH, AND IT IS ALMOST COMPLETELY COVERED WITH STONES AND HOSPITALIZED TO REPLACE THE IMPLANTED STENT. THE PATIENT WAS ALSO EXPOSED TO BODILY FLUID.
Patient problems: Exposure to Body Fluids
MAUDE report 24820776 ↗MalfunctionJul 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT, THERE WAS A SPLIT IN THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554317 ↗MalfunctionJul 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, WHEN THE URETHRAL STENT PACKAGE WAS OPENED DURING THE OPERATION AND READY FOR PLACEMENT, IT WAS FOUND THAT THE DRAINAGE HOLE ON THE HEAD OF THE URETERAL STENT WAS BROKEN, AND THE STENT HAD BEEN REPLACED INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553994 ↗MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN THE STENT PACKAGE WAS OPENED DURING THE OPERATION AND READY FOR PLACEMENT, IT WAS FOUND THAT THE DRAINAGE HOLE ON THE HEAD OF THE URETERAL STENT WAS BROKEN, AND THE STENT WAS REPLACED DURING THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384677 ↗MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE URETHRAL STENT WAS DISASSEMBLED TO CUT THE SUTURE AND INSPECTED BEFORE BEING PLACED IN THE STENT, IT WAS FOUND THAT THE STENT HAD OBVIOUS CUT MARKS AND COULD NOT BE USED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373435 ↗MalfunctionJun 12, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT BEFORE USE, CUSTOMER NOTICED 786624 DID NOT HAVE A STENT IN THE BOX. BOX HAD 2 GUIDE WIRES INSTEAD OF A STENT AND A GUIDE WIRE. STENT BOX HAD 2 GUIDE WIRES AND NO STENT, CUSTOMER COULD NOT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194178 ↗MalfunctionDec 26, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT NEEDS TO BE PLACED ON THE PATIENT AFTER URETEROSCOPIC LITHOTOMY IN ORDER TO ELIMINATE THE OBSTRUCTION CAUSED BY VARIOUS BENIGN, MALIGNANT AND POST-TRAUMATIC CONDITIONS IN THE URETER. WHEN THE DOCTOR WAS PREPARED TO INSERT THE URETERAL STENT DURING THE OPERATION, THE STENT ITSELF WAS BLOCKED BY THE LABEL ON THE PACKAGE AND CANNOT BE SEEN AT ALL, AFTER THAT THE ITINERANT NURSE OPENED THE BAG, IT WAS FOUND THAT THE STENT SHAFT WAS BROKEN, AND THE SILK THREAD WAS ENTANGLED WITH THE STENT, SO THE PRODUCT CANNOT BE USED, RESULTING IN THE PROLONGATION OF THE OPERATION TIME. IN ORDER TO ENSURE THE COMPLETION OF THE OPERATION, THE SURGEON ASKED TO REOPEN AND PREPARE 2-3 SETS OF THE PRODUCT IN ADVANCE AND THEN PLACE IT, AND THE FOLLOW-UP OPERATION OF THE PATIENT WENT SMOOTHLY AND GRADUALLY RECOVERED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21018299 ↗MalfunctionOct 16, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT WAS ALREADY BROKEN IN THE PACKAGE, BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20462871 ↗MalfunctionJun 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHEN UNPACKED THE PACKAGE, CUT THE SILK THREAD, STRAIGHTEN THE PIG'S TAIL, AND WHEN THE PIG'S TAIL STRAIGHTENER WAS TAKEN OUT, THE STENT BROKE FROM THE DRAINAGE HOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460788 ↗MalfunctionMay 10, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT THE PATIENT UNDERWENT URETERAL STENT PLACEMENT IN THE OPERATING ROOM, NEEDED TO USE A 6F URETERAL STENT, USED A 786626 STENT SET DURING THE OPERATION, AND AFTER INSERTING THE GUIDEWIRE, OPENED THE STENT PACKAGE AND FOUND THAT THE STENT WAS A 4.7F STENT, SO IT COULD NOT BE USED, AND THEN REPLACED WITH A NEW STENT AND CONTINUED TO COMPLETE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19285782 ↗MalfunctionJan 10, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT WHEN THE USER OPENED THE 786426 BRACKET PACKAGE, THEY FOUND THAT IT WAS A 6F BRACKET INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484109 ↗
Other C. R. Bard, Inc. products
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- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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