Bard InLay Optima Ureteral Stent with HydroGlide GuidewireRecalls & reported problems across all models
C. R. Bard, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 123
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 12 models of Bard InLay Optima Ureteral Stent with HydroGlide Guidewire by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 123 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Sep 11, 2026 — classified as 18 injuries, 105 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (51 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 HydroGlide Guidewire problems
Device problems
- Material Fragmentation51
- Material Twisted/Bent7
- Accessory Incompatible6
- Calcified6
- Inadequate Instructions for Healthcare Professional5
- Wrong Label5
- Break4
- Component Missing4
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- Pain5
- No Known Impact Or Consequence To Patient4
- No Patient Involvement4
- Foreign Body In Patient3
- Hematuria3
- Unspecified Infection3
Bard InLay Optima Ureteral Stent with HydroGlide Guidewire models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 58 reports
- 19 reports
- 18 reports
- 16 reports
- 3 reports
- 2 reports
- 2 reports
- 1 report
- 1 report
- 1 report
- 1 report
- 1 report
Recent Bard InLay Optima Ureteral Stent with HydroGlide Guidewire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Accessory Incompatible
It was reported that this event indicates that the stent was not sliding smoothly. Discontinue use due to strong resistance from the guidewire during insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734403 ↗MalfunctionJun 26, 2026Nonstandard Device
IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING OF THE URETERAL STENT, REMOVED THE STENT, CUT THE SUTURE AT THE TAIL END, AND ACTIVATED THE COATING WITH STERILE WATER. DURING THE PROCEDURE, A DEFECT WAS DISCOVERED IN THE PIG-TAIL AT THE PROXIMAL END OF THE STENT, RENDERING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643265 ↗InjuryMay 22, 2026Material Fragmentation
IT WAS REPORTED THAT WHEN A URINARY STENT WAS INSERTED, THE TIP OF THE TIGER TAIL CAME LOOSE AND FELL INTO THE URETER. IT WAS REPORTEDLY REMOVED VIA ENDOSCOPY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Insufficient Information
MAUDE report 25260345 ↗MalfunctionMar 12, 2026Accessory Incompatible
IT WAS REPORTED THAT WHEN PLACING A STENT, THE STENT DID NOT MOVE UP ALONG THE GUIDEWIRE, RESULTING IN AN ACCORDION PHENOMENON. THERE WAS NO SMOOTH STENT PLACEMENT IN THE CURRENT ACCORDION SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584752 ↗MalfunctionDec 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING USE, THE STENT RUPTURED NEAR THE RENAL PELVIS LOOP; THE STENT BROKE WHEN THEY ATTEMPTED TO CUT THE SUTURES AND PULL IT OUT AFTER DEPLOYMENT. SINCE THE SUTURES ON THE BLADDER SIDE WILL BE CUT WITH SCISSORS, IT WAS UNLIKELY THAT THE SCISSORS WILL COME INTO CONTACT WITH THE RENAL PELVIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23890474 ↗MalfunctionOct 29, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER OPENING IT AND USING IT FOR SURGERY, IT BROKE JUST BY TOUCHING IT, SO THE HEALTH PROFESSIONAL STOPPED USING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415243 ↗MalfunctionOct 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE, THERE WAS A HAIR STUCK IN THE OUTER SEAL OF THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23317203 ↗MalfunctionOct 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING USE THE TIP PIGTAIL OF THE STENTS BROKE OFF SIMPLY BY THREADING THE GUIDEWIRE THROUGH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23235956 ↗MalfunctionAug 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT ON (B)(6) 2025 DURING THE USE OF THE URETERAL STENT, AFTER OPENING THE PACKAGING AND REMOVING THE STENT, IT WAS DISCOVERED THAT THE STENT COATING WAS ROUGH AND TIGHT, MAKING IT IMPOSSIBLE TO INSERT INTO THE BODY. THE HOSPITAL CONTACTED THEIR COMPANY ON THE SAME DAY, AND THEY PROVIDED DETAILED INFORMATION TO THE COMPANY ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904280 ↗MalfunctionAug 13, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, IT WAS FOUND THAT THE URETERAL STENT WAS BROKEN AND THE WIRE WAS NOT REMOVED. REPLACED WITH A NEW STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794800 ↗MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE PIGTAIL OF THE URETERAL STENT HAD CRACKS, AND A REPLACEMENT STENT WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22741267 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2025, A UROLOGY PATIENT UNDERWENT URETEROLITHOTOMY. WHEN PLACING A URETERAL STENT, IT WAS FOUND THAT THE NEWLY OPENED URETERAL STENT WAS BENT, AND THE GUIDE WIRE COULD NOT PASS THROUGH. THE URETERAL STENT MIGHT BE AT RISK OF FRACTURE. A NEW URETERAL STENT WAS RANDOMLY REPLACED TO COMPLETE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22739691 ↗MalfunctionJul 21, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE END ACCESS URETERAL STENT GUIDE WIRE SHAFT WAS FRAYED, SO THE CUSTOMER DISCONTINUED USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22555626 ↗MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING SURGERY, WHEN THE DOCTOR OPENED THE INNER LAYER, IT WAS FOUND THAT THE URETHRAL STENT WAS FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458104 ↗MalfunctionJul 3, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
IT WAS REPORTED THAT THE URETHRAL STENT WAS BENDING. THE PIGTAIL WAS BENT NEAR THE TIP BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394792 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
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- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- 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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