Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10801741014489), received between Sep 6, 2017 and Apr 11, 2026 — classified as 21 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (61 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT (B)(6) 2026 MEDICAL STAFF FOR THE PATIENT TO PERFORM URETERAL STONE SURGERY, THE USE OF URETERAL STENTS DURING THE OPERATION FOUND THAT A SECTION OF THE STENT WAS TWISTED AND KINKED. PUSHING THE TUBE WAS DIFFICULT TO CAUSE THE SURGEON FAILED TO GIVE THE PATIENT A SUCCESSFUL PLACEMENT OF THE TUBE, IN ORDER TO AVOID MEDICAL MALPRACTICE, IMMEDIATELY REOPEN A NEW STENT, THE OPERATION WAS SUCCESSFULLY COMPLETED, THE REPORT OF THE RELEVANT DEVICE ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849217 ↗
• InjuryDec 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT AFTER STENT TUBE PLACEMENT, THE PATIENT'S INFECTION INDICATORS WERE EXTREMELY HIGH, AND THE STENT TUBE WAS COVERED WITH FLOCCULENT MATERIAL. FOLLOWING REMOVAL OF THE STENT TUBE, THE PATIENT'S INDICATORS RETURNED TO NORMAL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23715875 ↗
• MalfunctionOct 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, FRACTURE WAS DISCOVERED UPON DISASSEMBLY OF THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357707 ↗
• InjuryOct 17, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2021, DUE TO RIGHT FLANK AND ABDOMINAL PAIN FOR 3 DAYS. ON (B)(6) 2021, THE PATIENT UNDERWENT HOLMIUM LASER LITHOTRIPSY OF THE MIDDLE AND UPPER SEGMENTS OF THE RIGHT URETER WITH URETEROSCOPIC GUIDANCE AND RIGHT URETERAL STENT PLACEMENT. ONE URETERAL STENT WAS PLACED DURING THE OPERATION, THE PROCEDURE WENT SMOOTHLY, AND THE STENT DRAINAGE WAS UNOBSTRUCTED. ON (B)(6) 2021, THE PATIENT RETURNED TO THE HOSPITAL AS INSTRUCTED FOR URETERAL STENT REMOVAL. DURING THE PROCEDURE, A LARGE NUMBER OF STONES WERE FOUND ADHERED TO THE SURFACE OF THE URETERAL STENT. MOST OF THE STONES WERE FRAGMENTED USING PNEUMATIC LITHOTRIPSY, AND THE STENT WAS COMPLETELY REMOVED WITH FOREIGN BODY FORCEPS. SMALL STONE FRAGMENTS REMAINED ON THE SURFACE, WITH MINOR BLEEDING OBSERVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 23330674 ↗
• InjuryOct 17, 2025Calcified; Calcified

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LASER LITHOTRIPSY AND LEFT URETERAL STENT PLACEMENT ON (B)(6) 2021. THE PROCEDURE WAS UNEVENTFUL, AND THE INTERNAL STENT PROVIDED UNOBSTRUCTED DRAINAGE. ON (B)(6) 2025, THE PATIENT RETURNED TO THE HOSPITAL AS INSTRUCTED FOR URETERAL STENT REMOVAL. DURING THE PROCEDURE, EXTENSIVE STONE ADHESION WAS OBSERVED ALONG THE ENTIRE SURFACE OF THE URETERAL STENT, COMPLICATING THE EXTRACTION. FOREIGN BODY FORCEPS WERE USED TO REMOVE THE STONES, AFTER WHICH THE URETERAL STENT WAS SUCCESSFULLY EXTRACTED INTACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23330586 ↗
• MalfunctionSep 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED, DURING THE PREOPERATIVE PROCEDURE, WHEN OPENING THE URETERAL STENT AND ADVANCING THE GUIDEWIRE, THE STENT TUBE BECAME OBSTRUCTED, PREVENTING THE GUIDEWIRE FROM PASSING THROUGH. HOWEVER, THE NEWLY DEPLOYED STENT ALLOWED THE GUIDEWIRE TO PASS SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073666 ↗
• MalfunctionSep 8, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING URETEROSCOPY LITHOTRIPSY, UPON INSTALLING THE STENT, IT WAS DISCOVERED THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE STENT, RESULTING IN STENT TUBING OBSTRUCTION. AFTER REPLACING THE STENT WITH A NEW ONE, THE ISSUE REMAINED UNRESOLVED IT WAS ONLY RESOLVED UPON REPLACING THE STENT ONCE MORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993964 ↗
• MalfunctionJul 8, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE USING THE URETERAL STENT, DOUBLE-J PART WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438018 ↗
• MalfunctionJul 1, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE THE URETERAL STENT DOUBLE-J WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374303 ↗
• MalfunctionJun 24, 2025Fracture; Difficult to Open or Remove Packaging Material; Fracture; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING THE URETERAL STENT PLACEMENT PROCESS, THERE WAS A JAM WITH THE GUIDEWIRE INCLUDED IN THE PACKAGING, WHICH CAUSED THE STENT TO BREAK DURING THE SEPARATION PROCESS. THE WIRE WAS REMOVED. A NEW STENT HAD BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320981 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE SURGERY, WHEN OPENING THE URETERAL STENT AND REMOVING THE PIGTAIL STRAIGHTENER, THE STENT HAD BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166296 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE THE SURGERY, WHEN THE STENT WAS OPENED AND REMOVING THE PIG TAIL STRAIGHTENER, THE BRACKET BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166288 ↗
• MalfunctionApr 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DIRECTOR OPENED THE PRODUCT PACKAGING AFTER CHECKING THAT THE OUTER PACKAGING WAS INTACT, UNPACKED THE PRODUCT MODEL 777426 URETERAL STENT, CUT THE SILK THREAD WITH SCISSORS, AND THEN STRETCHED OUT THE STENT AND FOUND THAT THE STENT WAS BROKEN IN THE MIDDLE AND THE OPERATION COULD NOT BE COMPLETED. THE OPERATION WAS COMPLETED AFTER REPLACING IT WITH THE SAME PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847585 ↗
• MalfunctionJan 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2024, THEY OPENED THE PRODUCT PACKAGE AFTER CHECKING THAT THE OUTER PACKAGE WAS INTACT, REMOVED THE PRODUCT MODEL 777426 URETERAL STENT, AND AFTER CUTTING THE FILAMENT WITH SCISSORS WITH THE INTENTION OF PLACING THE TUBE, THEY FOUND THAT THE RENAL PELVIC PORT WAS BROKEN AND THEY COULD NOT COMPLETE THE PROCEDURE, AND REPLACED THE SAME PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124434 ↗
• MalfunctionNov 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON OCTOBER 23, 2024, THE CUSTOMER OPENED THE PRODUCT PACKAGE AFTER CHECKING THAT THE OUTER PACKAGE WAS INTACT, REMOVED THE PRODUCT URETERAL STENT, AND AFTER CUTTING THE FILAMENTS WITH SCISSORS WITH THE INTENTION OF PLACING THE TUBE, THEY FOUND THAT THE RENAL PELVIC PORT WAS BROKEN AND THEY COULD NOT COMPLETE THE PROCEDURE, AND REPLACED THE SAME PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673031 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER TOOK OUT THE URETERAL STENT, REMOVED THE WIRE, AND INSERTED THE STENT ALONG THE GUIDE WIRE. IT WAS FOUND THAT THE SURFACE OF THE STENT BODY WAS DAMAGED. IT WAS ALSO STATED THAT IT RESULTED IN PROLONGED SURGERY REQUIRED A NEW STENT TO BE USED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20440449 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER STRETCHED THE URETERAL STENT DURING THE EXTRACTION PROCESS WITH THE STENT, BREAKAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438723 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT WAS TAKEN OUT TO REMOVE THE WIRE, AND THE STENT BROKE DURING THE PROCESS OF STRAIGHTENING THE GUIDE WIRE ON THE STENT. THIS WAS IDENTIFIED DURING INITIAL USE AND WAS NOT USED ON THE PATIENT. STATED THAT THERE WAS A PROLONGED SURGERY AND NEEDED A NEW STENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20438720 ↗
• MalfunctionOct 10, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER FOUND THAT THE URETERAL STENT WAS BROKEN WHEN THEY UNPACKED IT BEFORE THE OPERATION. AFTER UNPACKING IT, NO SILK THREAD WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416742 ↗
• MalfunctionJul 23, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS A LARGE RESISTANCE BETWEEN THE STENT AND THE BUILT-IN STEEL GUIDE WIRE, AND THE STENT COULD NOT BE PUSHED IN SMOOTHLY, RESULTING IN THE STENT BREAKING DURING THE PUSHING PROCESS. THE WIRE WAS REMOVED, AND PART OF THE STENT ENTERED THE HUMAN BODY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19804866 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE SURGICAL DEPARTMENT OF OUR HOSPITAL ON (B)(6) 2024 FOR RENAL URETERAL STONES WITH HYDROPS AND INFECTION, PERINEPHRITIS, FATTY LIVER. THEY ENTERED THE OPERATING ROOM AT 09:20 ON (B)(6) 2024 AND UNDERWENT TRANSURETHRAL URETEROSCOPIC URETERAL LASER LITHOTRIPSY AND TRANSURETHRAL URETERAL STENT PLACEMENT UNDER GENERAL ANESTHESIA. AT 10:15, THE SURGEON PREPARED TO PLACE THE URETERAL STENT. THE ASSISTANT DOCTOR CHECKED THAT THE OUTER PACKAGING OF THE URETERAL STENT WAS NOT DAMAGED OR LEAKED, AND IT WAS WITHIN THE PRODUCTION VALIDITY PERIOD. WHEN THE OUTER PACKAGING WAS OPENED, IT WAS FOUND THAT THE LOWER SECTION OF THE URETERAL STENT HAD CRACKS AND COULD NOT BE USED. THE SAME MODEL OF URETERAL STENT WAS IMMEDIATELY REPLACED, AND THE OPERATION WAS REPEATED. THE OPERATION TIME WAS DELAYED BY ABOUT 2 MINUTES. THE OPERATION ENDED AT 10:30, AND THE PATIENT WAS SENT TO THE ANESTHESIA RECOVERY ROOM AFTER THE OPERATION. THE CHANGES IN VITAL SIGNS AND URINE DRAINAGE WERE CLOSELY OBSERVED, AND THE ANESTHESIA WAS RECOVERED. AT 11:00, THE PATIENT RETURNED TO THE WARD SAFELY AFTER WAKING UP FROM ANESTHESIA. DURING THE POSTOPERATIVE FOLLOW-UP, THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585529 ↗
• MalfunctionMay 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE DOCTOR WAS READY TO IMPLANT THE URETERAL STENT, THEY OPENED THE PACKAGE AND TOOK OUT THE URETERAL STENT. ONE END OF THE PIGTAIL FALLS AND CANNOT BE USED. THE SURGERY WAS DONE BY REOPENING THE NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320849 ↗
• MalfunctionMay 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOCTOR WAS PREPARING FOR URETERAL STENT IMPLANTATION, THEY OPENED THE OUTER PACKAGING AND FOUND THAT THE URETERAL STENT ROD WAS BROKEN AND UNUSABLE. THE SURGERY WAS DONE BY REOPENING THE NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249283 ↗
• MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AT 17:30 ON (B)(6) 2023, DURING THE PATIENT'S CYSTOSCOPIC DOUBLE-J TUBE INSERTION IN THE CYSTOSCOPY ROOM, AFTER DISASSEMBLING THE BLADDER URETERAL STENT, THEY FOUND THAT THE URETERAL STENT IN THE PACKAGE WAS BROKEN INTO TWO PARTS, AND THEY IMMEDIATELY REPORTED IT TO THE CATHETERIZING DOCTOR, THE HEAD NURSE, LATER REPLACED THE NEW BLADDER URETERAL STENT. EVENTS EXTEND THE PATIENT'S SURGICAL TIME AND INCREASE RISKS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19169992 ↗
• MalfunctionApr 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER OPENED THE URETERAL STENT PACKAGE. AFTER OPENING THE STERILE PACKAGE, THEY FOUND THAT THE TAIL OF THE STENT WAS BROKEN. FOR INSPECTION PURPOSES, OPEN THE INNER PACKAGING OF THE STENT AND TAKE OUT THE STENT, THE STENT WAS INDIVIDUALLY WRAPPED IN PLASTIC. SINCE THE TAIL END OF THE STENT WAS BROKEN, THEY COMPLAINED THAT THE DETACHED TAIL END WAS NOT RETAINED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 08APR2024, THE PRODUCT WAS NOT USED ON PATIENTS AND PATIENTS WERE NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169964 ↗