Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787426Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801741015363), received between Nov 8, 2018 and Jun 26, 2026 — classified as 1 injury, 15 malfunctions.

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

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PHYSICIAN OPENED THE STERILE PACKAGING OF THE URETERAL STENT, REMOVED THE STENT, CUT THE SUTURE AT THE TAIL END, AND ACTIVATED THE COATING WITH STERILE WATER. DURING THE PROCEDURE, A DEFECT WAS DISCOVERED IN THE PIG-TAIL AT THE PROXIMAL END OF THE STENT, RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643265 ↗
• MalfunctionAug 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, IT WAS FOUND THAT THE URETERAL STENT WAS BROKEN AND THE WIRE WAS NOT REMOVED. REPLACED WITH A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794800 ↗
• InjuryJan 31, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THIS URETERAL STENT WAS SOLD TO THE AFFILIATED HOSPITAL OF (B)(6) UNIVERSITY ON (B)(6) 2025. ON (B)(6) 2025, WHEN THE HOSPITAL WAS IMPLANTING A URETERAL STENT FOR A PATIENT, THE STENT GOT STUCK IN THE URETER. THE DOCTOR LATER PULLED IT OUT WITH AN INSTRUMENT, BUT IT COULD NO LONGER BE USED DUE TO CONTAMINATION.

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

  MAUDE report 21285268 ↗
• MalfunctionOct 1, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT NEEDED A URETERAL STENT AFTER URETEROSCOPIC LITHOTOMY TO ELIMINATE OBSTRUCTION CAUSED BY VARIOUS BENIGN, MALIGNANT AND POST-TRAUMATIC DISEASES IN THE URETER. WHEN THE URETERAL STENT WAS TO BE INSERTED DURING THE OPERATION, THE CIRCULATING NURSE OPENED THE PACKAGE AND FOUND THAT THE STENT ROD WAS BROKEN WHEN INSERTING THE GUIDE WIRE, WHICH PROLONGED THE OPERATION. THE SURGEON REQUESTED TO REOPEN THE PRODUCT (STOCK 2-3 SETS IN ADVANCE). THE PATIENT'S SUBSEQUENT OPERATION WENT SMOOTHLY, AND THE PATIENT GRADUALLY RECOVERED.

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

  MAUDE report 20344037 ↗
• MalfunctionNov 27, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE STENT WAS DISCONNECTED DURING PERCUTANEOUS NEPHROSCOPY AFTER UNPACKING AND IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209515 ↗
• MalfunctionNov 14, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMERS STATED THAT THE GUIDEWIRE OF THEIR RECENT BRACKET WAS SIGNIFICANTLY THICKER THAN THE STENT. THE GUIDE WIRE USED WITH THE 426 STENT WAS THICKER THAN THE 0.035 GUIDEWIRES RESULTING IN OVER TIGHTENING AND DIFFICULTY IN OPERATION DURING USE. THE HEALTH CARE PROFESSIONAL HAD A POOR CUSTOMER USE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132316 ↗
• MalfunctionDec 27, 2022Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT THE DOUBLE J-SHAPED TUBING WAS PLANNED TO BE PLACED AFTER OPERATION. UPON UNPACKING, THE PIGTAIL WAS NOT COILED. A NEW STENT WAS UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052857 ↗
• MalfunctionSep 26, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THERE WERE BURRS AT THE TIP OF THE INLAY OPTIMA URETERAL STENT, MAKING IT UNUSABLE. THE STENT WAS NOT USED AND THEY INSERTED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487707 ↗
• MalfunctionSep 24, 2022Calcified; Calcified

  IT WAS REPORTED THAT THE STENT WAS COVERED WITH CALCULI ONE MONTH AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476110 ↗
• MalfunctionSep 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, THE TWO PIGTAIL RINGS OF THE URETERAL STENT WERE FOUND TO BE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447360 ↗
• MalfunctionSep 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS FOUND TO BE RUPTURED UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419690 ↗
• MalfunctionJan 12, 2022Partial Blockage; Device Contamination with Chemical or Other Material; Partial Blockage; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE URETER WAS BLOCKED BY ITSELF AND COULD NOT BE USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237022 ↗
• MalfunctionDec 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED DURING OPERATION, THE URETERAL STENT WAS FOUND TO BE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981413 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ONE SECTION OF THE TIP OF THE PRODUCT WAS FOUND MISSING AFTER THE PACKAGE WAS OPENED. ALSO STATED THAT IT MADE THE PRODUCT IMPOSSIBLE TO USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307209 ↗
• MalfunctionApr 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT WAS FOUND TO BE BROKEN AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665337 ↗
• MalfunctionNov 8, 2018Break

  IT WAS REPORTED THAT DURING THE URETEROSCOPY, THE OPENING OF THE RETENTION TUBE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8052094 ↗