Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787726Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10801741015523), received between Jul 26, 2021 and Jul 9, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionApr 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, WHEN USING THE URETERAL STENT, NANTONG AFFILIATED HOSPITAL FOUND THAT THE ACTUAL 787726 WAS BROKEN AND COULD NOT BE USED AFTER OPENING THE PACKAGE DURING THE OPERATION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT PATIENT NOT PARTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934517 ↗
• MalfunctionApr 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE FLEXIBLE URETEROSCOPY LITHOTOMY, THE CUSTOMER OPENED THE TRANSPARENT PACKAGE. WHEN PREPARING THE URETERAL STENT, THEY FOUND THAT THE SMALL HOLE SECTION IN THE MIDDLE WAS BROKEN, THE SILK THREAD WAS INTACT, AND THE URETERAL STENT WAS NOT USED. THEN A NEW STENT WAS USED TO CONTINUE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019476 ↗
• MalfunctionNov 1, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2023, THE USER OPENED THE PACKAGE AND TOOK OUT THE 787726 MODEL URETERAL STENT AFTER CHECKING THE STATE OF THE OUTER PACKAGING WAS CORRECT. THE GUIDEWIRE COULD NOT BE INSERTED AND SO WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046985 ↗
• MalfunctionSep 15, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT ON OF THE STENT BOXES WERE PULLED THIS WEEK AND THE BOX WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754612 ↗
• MalfunctionApr 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS RUPTURED BEFORE USE. THE STENT WAS UNABLE TO BE USED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742883 ↗
• MalfunctionSep 24, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE OUTER PACKAGE WAS INTACT AND THE STENT WAS FOUND TO BE RUPTURED PRIOR TO USE UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476202 ↗
• MalfunctionJul 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE USER OPENED THE PACKAGE OF THE URETERAL STENT FOLLOWING AN EXAMINATION SHOWING NO ABNORMALITY ON (B)(6) 2022. THERE WAS NO GUIDE WIRE WAS SEEN INSIDE AND THE URETERAL STENT WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052460 ↗
• MalfunctionJul 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN USER OPENED THE PACKAGE OF THE URETERAL STENT THERE WAS NO GUIDE WIRE WAS SEEN INSIDE AND THE URETERAL STENT WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041573 ↗
• MalfunctionJun 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CUSTOMER OPENED THE PACKAGE AND REMOVED THE INLAY OPTIMA URETERAL STENT AFTER CONFIRMING THAT THERE WAS NO ABNORMALITY WITH THE OUTER PACKAGE. DURING THE PROCESS OF DELIVERING THE PIGTAIL STRAIGHTENER TO THE RENAL END, THE STENT WAS BROKEN INTO THREE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829034 ↗
• MalfunctionApr 26, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE PACKAGE, BUT WHEN IT WAS OPENED, THE URETERAL STENT WAS FOUND TO BE RUPTURED AND THE GUIDEWIRE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14204876 ↗
• MalfunctionApr 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE PACKAGE, BUT WHEN IT WAS OPENED, THE URETERAL STENT WAS FOUND TO BE RUPTURED AND THE GUIDEWIRE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192720 ↗
• MalfunctionApr 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, ON (B)(6) 2022 THE USER OPENED THE PACKAGE AND TOOK OUT THE INLAY OPTIMA URETERAL STENT AFTER CHECKING THAT THE OUTER PACKAGING WAS CORRECT. DURING THE PROCESS OF PUSHING THE PIGTAIL STRAIGHTENER TO THE RENAL END, THE STENT WAS BROKEN INTO THREE SEGMENTS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07-APR-2022 IT WAS STATED THAT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136778 ↗
• MalfunctionNov 10, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, ENCRUSTATION, INFECTION, AND URINARY SYMPTOMS WHILE USING A URETERAL STENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786011 ↗
• MalfunctionNov 9, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, ENCRUSTATION, INFECTION, AND URINARY SYMPTOMS WHILE USING A URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778635 ↗
• InjuryNov 9, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, ENCRUSTATION, INFECTION, AND URINARY SYMPTOMS WHILE USING A URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION AND URINARY SYMPTOMS.

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

  MAUDE report 12778535 ↗
• MalfunctionNov 9, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, ENCRUSTATION, INFECTION, AND URINARY SYMPTOMS WHILE USING A URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778438 ↗
• MalfunctionNov 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, ENCRUSTATION, INFECTION, AND URINARY SYMPTOMS WHILE USING A URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778424 ↗
• MalfunctionJul 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETHRAL STENT WAS FOUND RUPTURED WHEN THE PACKAGE WAS OPENED. IT WAS ALSO STATED THAT THE OUTER PACKAGE OF THE PRODUCT REMAINED INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224211 ↗