Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777726Recalls & 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
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10801741014625), received between Jan 22, 2018 and Apr 28, 2025 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Material Fragmentation6
- Accessory Incompatible2
- Appropriate Device Problem Term/Code Not Available1
- Biocompatibility1
- Calcified1
- Device Dislodged or Dislocated1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient8
- No Patient Involvement6
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT BEFORE USE IT WAS FOUND THAT THE STENT END WAS CRACKED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2025, STATED THAT THE SAMPLE WAS DISCARDED AND BEFORE DISASSEMBLING THE TABLE, IT WAS FOUND THAT THERE WAS A CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917564 ↗MalfunctionApr 4, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRONT END OF THE WETTING PIPELINE OF THE STENT WAS BROKEN BEFORE IT WAS PLACED, SO IT WAS REPORTED AS A DEFECTIVE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773657 ↗InjuryJan 23, 2025Calcified; Calcified
IT WAS REPORTED THAT THE INCRUSTATION OCCURRED 50 DAYS AFTER STENT PLACEMENT, MAKING STENT REMOVAL IMPOSSIBLE. THE SOLUTION WAS URETERAL SCLEROSCOPIC REMOVAL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21217125 ↗MalfunctionNov 22, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2024 AT 10:00 A.M., THE PATIENT UNDERWENT A LEFT URETERAL STENT PLACEMENT IN THE CYSTOSCOPY ROOM, AND DURING THE PHYSICIAN USING THE ITEM, THE URETERAL STENT WAS DISASSEMBLED AND FOUND TO BE IN A TWO SECTIONED STATE AND INOPERABLE. AFTER OBTAINING THE PATIENT UNDERSTANDING, THE URETERAL STENT WAS IMMEDIATELY REPLACED WITH A NEW ONE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 21NOV2024, CONFIRMED THAT THE STENT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756753 ↗MalfunctionJul 20, 2022Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn
IT WAS REPORTED THAT JJ TIP OF THE URETERAL STENT WAS SPLIT. ANOTHER DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064857 ↗MalfunctionDec 31, 2021Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT IT WAS UNABLE TO GUIDE THROUGH THE GUIDE WIRE OF THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13128650 ↗MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION, PAIN, DISCOMFORT AND INFECTION BY URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12748161 ↗InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND PAIN, DISCOMFORT AND INFECTION BY URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 12745447 ↗MalfunctionNov 3, 2021Migration; Migration
IT WAS REPORTED THAT PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND PAIN, DISCOMFORT AND INFECTION BY URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12745355 ↗MalfunctionJul 8, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE STENT WAS RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12137351 ↗MalfunctionMay 30, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE BARD URETERAL STENT SHAFT WAS FOUND TO BE RUPTURED AFTER OPENING THE PACKAGE. THE OUTER PACKAGE OF THE PRODUCT WAS CHECKED FOR INTEGRITY AND NO ABNORMALITIES WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11905792 ↗MalfunctionJun 17, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8705648 ↗MalfunctionMay 9, 2019Break
IT WAS REPORTED THAT THE TIP OF THE STENT WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8594694 ↗MalfunctionFeb 6, 2019Break
IT WAS REPORTED THAT WHILE UNPACKING, THE STENT WAS FOUND TO BE BROKEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8310958 ↗MalfunctionSep 25, 2018Break
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TIP OF THE STENT WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7906277 ↗MalfunctionAug 23, 2018Accessory Incompatible; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Accessory Incompatible
IT WAS REPORTED THAT THE PUSHER FAILED. THE USER ATTEMPTED TO USE THE PUSHER TO ADVANCE THE STENT BUT FAILED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7809752 ↗MalfunctionMay 11, 2018Break
IT WAS REPORTED THAT THE DEVICE TIP WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7509108 ↗MalfunctionMay 1, 2018Break
IT WAS REPORTED THAT THE PIG TAIL (CATHETER TIP) WAS BROKEN PRIOR TO INSERTING INTO THE PATIENT
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7478553 ↗MalfunctionJan 22, 2018Break
IT WAS REPORTED THAT THE COIL SITE OF THE DEVICE WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7210170 ↗
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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