Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777624Recalls & reported problems
C. R. Bard, Inc. · INLAY URETERAL STENT W/HYDROGLIDE GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Ureteral Stent with HydroGlide Guidewire (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard InLay ureteral stent is a tube placed in the kidney to drain urine, packaged with a HydroGlide guidewire. The 34 reports mostly describe the stent cracking, snapping or breaking — sometimes before use, sometimes while a doctor was placing it — plus difficulty pushing it into place, and in one case a stent smaller than the size printed on the package. Two injuries were reported and no deaths. There are no recalls naming this device.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10801741014540), received between May 2, 2018 and Sep 25, 2025 — classified as 2 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (14 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 Fragmentation14
- Break9
- Accessory Incompatible2
- Biocompatibility2
- Patient Device Interaction Problem2
- Calcified1
- Defective Component1
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Patient Involvement9
- No Known Impact Or Consequence To Patient6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Consequences Or Impact To Patient2
- Exposure to Body Fluids1
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2025Accessory Incompatible; Defective Component; Accessory Incompatible; Defective Component
IT WAS REPORTED THAT, THE URETERAL STENT WAS HARD TO PUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23148055 ↗MalfunctionSep 16, 2025Fracture; Fracture
IT WAS REPORTED THAT URETERAL STENT TIP WAS CRACKED. IT WAS CHANGED TO NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065001 ↗MalfunctionFeb 25, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE NURSE STATED THAT DURING THE EXECUTION, THE DOCTOR FOLLOWED THE PREVIOUS METHOD, BUT THIS TIME THE STENT SUDDENLY BROKE, SO THEY REPORTED IT AS A DEFECTIVE PRODUCT. PATIENT WAS EXPOSED TO BODILY FLUID. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Exposure to Body Fluids
MAUDE report 21460745 ↗MalfunctionJul 26, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ONE END OF THE URETERAL STENT WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838733 ↗MalfunctionJul 18, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE URETERAL STENT WAS NOT EASY TO PUSH SEEMS LIKE THERE WAS RESISTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19770708 ↗MalfunctionJul 17, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT STENT SIZE INDICATED OUTSIDE THE POUCH WAS 6X24, ACTUAL STENT INSIDE THE SEALED POUCH WAS 4.27X24.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19761173 ↗MalfunctionDec 7, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ENDOSCOPE SHOWED THAT THE URETERAL STENT HAD A CRACK AT ONE END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18283097 ↗MalfunctionJul 20, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN UPON OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17364516 ↗MalfunctionJul 13, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT DOUBLE J FRONT WAS RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17316438 ↗MalfunctionJun 9, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CATHETER PLACEMENT WAS PERFORMED IN THIS PATIENT WITH CALCULI FOR DRAINAGE ON (B)(6). ONCE THE PACKAGE WAS OPENED, THE URETERAL STENT WAS FOUND TO BE RUPTURED. THE CATHETER WAS NOT USED AND WAS REPLACED WITH ANOTHER PRODUCT FOR CATHETER PLACEMENT, CAUSING NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17098280 ↗MalfunctionSep 28, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRONT TIP OF THE URETERAL STENT WAS FOUND TO BE BROKEN. THEREFORE, A NEW STENT WAS UNPACKED TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15496112 ↗MalfunctionAug 30, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE TUBE OF THE STENT HAD CREASES AND THE CUSTOMER CHANGED A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15324401 ↗MalfunctionAug 15, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE USER GENTLY PULLED THE STENT AND THE DEVICE WAS BROKEN. A NEW STENT HAD BEEN UNPACKED TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15225978 ↗MalfunctionApr 26, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER OPENED THE PACKAGE, THE URETERAL STENT BROKE AS THE COIL SEPARATED WITH THE STRAIGHT SITE. IT WAS STATED THAT A NEW STENT HAD BEEN UNPACKED TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14208124 ↗MalfunctionDec 30, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT BROKE, AND THE COIL SEPARATED FROM THE STRAIGHT SITE AFTER OPENING THE PACKAGE. IT WAS MENTIONED THAT A NEW URETERAL STENT HAD BEEN UNPACKED FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13121657 ↗MalfunctionNov 4, 2021Calcified; Calcified
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION AND URETERAL REFLUX WHILE USING THE BARD URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751231 ↗MalfunctionNov 3, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT BROKE AND THE COIL SEPARATED FROM THE STRAIGHT SITE AFTER OPENING THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746675 ↗InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED URETERAL REFLUX, PAIN, DISCOMFORT AND URINARY SYMPTOMS. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 12745824 ↗InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION AND URETERAL REFLUX WHILE USING THE BARD URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR EDEMA AND URETERAL REFLUX.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema
MAUDE report 12745564 ↗MalfunctionOct 22, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT BROKE, AND THE COIL SEPARATED FROM THE STRAIGHT SITE AFTER OPENING THE PACKAGE. IT WAS CONFIRMED THAT THE CUSTOMER HAD BEEN REPLACED WITH A URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681895 ↗MalfunctionJun 7, 2021Accessory Incompatible; Material Protrusion/Extrusion; Accessory Incompatible; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE INNER TUBE POLYAMIDE WAS OUT TOGETHER ALONG WITH THE GUIDEWIRE WHILE REMOVING THE GUIDEWIRE. STATED THAT ANOTHER NEW TUMOR STENT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11945879 ↗MalfunctionMar 24, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CRACK WAS FOUND ON DOUBLE J WALL STENT. CHANGE A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11565989 ↗MalfunctionSep 21, 2020Break; Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRONT TIP OF THE STENT WAS FOUND BROKEN PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10560398 ↗MalfunctionFeb 21, 2020Break
IT WAS REPORTED THAT THE TIP OF THE STENT WAS BROKEN PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 9739662 ↗MalfunctionDec 16, 2019Break
IT WAS REPORTED THAT THE BARD URETHRAL STENT WAS FOUND BROKEN UPON OPENING THE PACKAGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9476741 ↗
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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