Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626Recalls & 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, a thin tube placed in the ureter with a guidewire, has 116 adverse event reports on file. Many describe the stent tube or its pigtail breaking or fragmenting, often found when the package was opened, and some describe wrong labeling. The reports include no deaths and 15 injuries, and the number of reports fell from 16 to 1 over the last 12 months. No recalls name 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
- 118
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10801741014557), received between Apr 12, 2017 and Sep 15, 2026 — classified as 16 injuries, 102 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (43 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 Fragmentation43
- Wrong Label21
- Break11
- Biocompatibility8
- Calcified8
- Patient Device Interaction Problem6
- Component Missing5
- Accessory Incompatible3
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Patient Involvement16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available13
- No Known Impact Or Consequence To Patient13
- Pain6
- Discomfort4
- Exposure to Body Fluids4
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Calcified
Patient problems: Back pain
MAUDE report 50781995 ↗MalfunctionSep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698892 ↗MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE FRACTURE WAS FOUND IN THE STENT WHEN DISASSEMBLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708196 ↗MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING URETEROSCOPY LITHOTRIPSY, WHEN OPENED THE PACKAGE AND FOUND THAT THE PIGTAIL AT THE LOWER END OF THE URETERAL STENT TUBE WAS FRACTURED AND DAMAGED, SO A NEW PRODUCT WAS OPENED FOR SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22781998 ↗MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE URETEROSCOPE LITHOTRIPSY, THE DOCTOR OPENED THE PACKAGING AND FOUND THAT THE LOWER END OF THE URETERAL STENT TUBE WAS BROKEN AND DAMAGED, SO A NEW PRODUCT WAS OPENED FOR THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22781997 ↗MalfunctionJul 29, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, URETERAL STENT WAS FOUND TO BE BROKEN BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22643996 ↗MalfunctionJul 28, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT URETERAL STENT D-J TIP WAS NOT SMOOTH AND COULD NOT BE PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22637145 ↗MalfunctionJul 11, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2025, DURING THE SURGERY, UPON OPENING THE PACKAGING, IT WAS FOUND THAT THE STENTS TUBE WAS BROKEN. A NEW URETERAL STENT WAS REPLACED TO CONTINUE THE SURGICAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22479652 ↗MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE URETEROSCOPIC LITHOTRIPSY, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE PIGTAIL AT THE LOWER END OF THE STENT TUBE WAS BROKEN AND DAMAGED, SO OPENED A NEW PRODUCT TO PERFORM THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384679 ↗MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE URETEROSCOPIC LITHOTRIPSY, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE PIGTAIL AT THE LOWER END OF THE URETERAL STENT WAS BROKEN AND DAMAGED. THEY OPENED A NEW PRODUCT FOR SURGERY AND FOUND THAT THE PIGTAIL AT THE LOWER END OF THE STENT WAS STILL BROKEN AND DAMAGED. THEY CONTINUED TO OPEN A NEW PRODUCT TO COMPLETE THE SURGERY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22384672 ↗MalfunctionMay 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2025, A URETERAL LITHOTRIPSY WAS PERFORMED. WHEN THE DOCTOR OPENED THE PACKAGE, THEY FOUND THAT THE PIGTAIL AT THE END OF THE STENT TUBE WAS BROKEN, AND THE SILK THREAD WAS FALLING OFF. THEN REPLACED THE PRODUCT WITH A NEW ONE FOR THE OPERATION, WHICH DID NOT CAUSE SERIOUS IMPACT ON THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21951259 ↗MalfunctionMar 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL STENT TUBE BROKE DURING SURGERY. PROLONGED THE PATIENT'S SURGERY TIME.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21678458 ↗InjuryMar 17, 2025Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT THE USER FELT STUCK WHEN USE THE PUSHER. THE PATIENT WAS EXPOSURE TO URINE. AS PER INTERNAL FOLLOW-UP NOTIFICATION RECEIVED ON 28APR2025, THE FELT STUCK WHEN USE THE PUSHER AT THE BEGINNING.
Patient problems: Exposure to Body Fluids
MAUDE report 21617987 ↗InjuryMar 17, 2025Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT THE USER FELT STUCK WHEN USE THE PUSHER. THE PATIENT WAS EXPOSURE TO URINE.
Patient problems: Exposure to Body Fluids
MAUDE report 21617982 ↗InjuryMar 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT UNPACKED AND OPENED THE STENT AND FOUND THAT THE HEAD END OF THE STENT WAS BROKEN AND UNUSABLE. PATIENT HAS BEEN EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Exposure to Body Fluids
MAUDE report 21547546 ↗MalfunctionMar 3, 2025Flaked; Flaked
IT WAS REPORTED THAT THERE ARE CREASES ON THE DOUBLE J OF THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504516 ↗MalfunctionJan 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE LOWER END OF THE URETERAL STENT WAS FOUND SPLIT WHEN THE PACKAGE WAS OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091898 ↗MalfunctionDec 24, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A URETERAL STENT PLACEMENT PROCEDURE ON (B)(6) 2024, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE END OF THE STENT SILK THREAD WAS BROKEN, THE SILK THREAD WAS IN A STATE OF DETACHMENT, SO IT WAS REPLACED WITH A NEW PRODUCT AND CONTINUED THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21011689 ↗MalfunctionDec 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE HEAD WAS BROKEN WHICH WAS FOUND AFTER OPENING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844156 ↗MalfunctionOct 24, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A URETERAL STENT WAS USED IN A URETERAL STONE SURGERY. WHEN THE PACKAGE WAS UNPACKED, IT WAS FOUND THAT THE URETERAL STENT WAS BROKEN. THE BROKEN PART WAS AT THE SILK THREAD LIGATION SITE. THE CUSTOMER DID NOT REMOVE THE SILK THREAD AND DIRECTLY DISPOSED OF THE BROKEN PART AND THE SILK THREAD AS MEDICAL WASTE. THE REMAINING SAMPLE WAS RETURNED. THE SURGERY WAS COMPLETED AFTER REPLACING A PACKAGE OF URETERAL STENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523128 ↗MalfunctionSep 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE CUSTOMER OPENED THE GUIDE WIRE THAT CAME WITH THE 777626 AND FOUND THAT THERE WAS A WAX-LIKE OBJECT ATTACHED TO THE GUIDE WIRE. AFTER LUBRICATING THE WIRE WITH WATER AND RUBBING IT BY HAND, THE WAX DID NOT COME OFF AND THE CUSTOMER WAS UNABLE TO CONTINUE WITH THE TRIAL. THE SOLUTION WAS TO OPEN ANOTHER BRAND OF GUIDEWIRE FOR TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20269355 ↗MalfunctionSep 11, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT URETERAL STENT WAS USED IN A URETERAL STONE SURGERY. WHEN THE PACKAGE WAS UNPACKED, IT WAS FOUND THAT THE URETERAL STENT WAS BROKEN. THE BROKEN PART WAS AT THE SILK THREAD LIGATION SITE. THE CUSTOMER DID NOT REMOVE THE SILK THREAD AND DIRECTLY DISPOSED OF THE BROKEN PART AND THE SILK THREAD AS MEDICAL WASTE. THE REMAINING SAMPLE WAS RETURNED. THE SURGERY WAS COMPLETED AFTER REPLACING A PACKAGE OF URETERAL STENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189408 ↗MalfunctionMay 24, 2024Wrong Label; Wrong Label
IT WAS REPORTED THAT CONTENTS INSIDE THE URETERAL STENT PACKAGING DID NOT MATCH WITH THE OUTER PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19390755 ↗MalfunctionMar 19, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ON (B)(6) 2024, THE KIDNEY STONE REMOVAL SURGERY WAS PERFORMED, AND THE PRODUCT WAS FOUND TO BE BROKEN WHEN THE PACKAGE WAS OPENED. IT WAS A STENT THAT WAS BROKEN WHEN USER OPENED THE PACKAGE. THE TRANSPARENT PLASTIC BAG INSIDE WAS OPENED AND IT WAS BRAND NEW AND UNUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928907 ↗MalfunctionFeb 12, 2024Calcified; Calcified
IT WAS REPORTED THAT ON (B)(6) 2023, THE DOCTOR ROUTINELY PLACED A URETERAL STENT FOR THE PATIENT AFTER STONE SURGERY, AND WHEN THE PATIENT RETURNED TO THE HOSPITAL FOR EXTUBATION ON (B)(6) 2023, THE DOCTOR FOUND THAT THERE WERE STONES ATTACHED TO THE SURFACE OF THE STENT TUBE, AND IT WAS DIFFICULT TO EXTUBATE. EFFORTS WERE MADE TO OBSERVE THE SYMPTOMS AFTER EXTUBATION, TEMPORARILY PLACED DISPOSABLE URETERAL CATHETERS TO SUPPORT THE URETERS, AND FOLLOW-UP DEPARTMENTS SUCCESSIVELY NOTIFIED PATIENTS WITH THE SAME BATCH OF STENT TUBES TO EXTUBATE AS SOON AS POSSIBLE TO AVOID THE FORMATION OF STENT STONES AND THE OCCURRENCE OF MEDICAL ADVERSE EVENTS. THREE CONSECUTIVE PATIENTS WITH THE SAME PRODUCT FROM THIS BATCH HAD SIMILAR STONES ATTACHED TO THE STENT TUBE, WHICH WERE EASY TO BREAK AND DIFFICULT TO REMOVE. THIS WAS CONSIDERED TO BE RELATED TO THE PRODUCT QUALITY OR SURFACE COATING OF THE STENT TUBE. THE DEVICE INJURY PERFORMANCE STATED THAT THE EVENT MIGHT HAVE CAUSED URINARY TRACT DAMAGE.
Patient problems: Insufficient Information
MAUDE report 18684623 ↗
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 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
- Contour™ M0061802230Boston Scientific Corporation · STENT, URETERAL70 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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