Bard® InLay Optima® Ureteral Stent 788628Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741015779), received between Nov 7, 2021 and Feb 19, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT URETERAL STENT WAS NOT PACKED CORRECTLY AND NO STERILE INNER PACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409858 ↗
• MalfunctionJan 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN PERFORMING URETEROSCOPIC LITHOTRIPSY, OPENED THE URETERAL STENT PACKAGE, REMOVED THE STENT AND FOUND THAT ONE END OF THE URETERAL STENT WAS BROKEN AT THE HEAD END, AND THE SILK THREADS WERE IN A STATE OF DETACHMENT. SO, THEY REPLACED IT WITH A NEW PRODUCT AND CONTINUED TO COMPLETE THE PROCEDURE. DELAY IN SURGERY.

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

  MAUDE report 21169075 ↗
• MalfunctionDec 16, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE URETERAL STENT WAS PACKAGED INCORRECTLY AND DID NOT HAVE A STERILE INNER PACKET AND STATED HAD TO BE WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939046 ↗
• MalfunctionDec 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, THE URETERAL STENT WAS TORN AT ABOUT 1CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901845 ↗
• MalfunctionJan 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE INLAY OPTIMA WAS OPENED, THE PERIPHERY OF THE HOLE WAS TORN ON ONE SIDE OF THE INLAY OPTIMA URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501590 ↗
• MalfunctionJun 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN DURING THE PROCEDURE. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 23JUN2023, STATED THAT THE DEVICE WAS NOT USED WITH THE PATIENT, SO NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237768 ↗
• MalfunctionFeb 3, 2022Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CATHETER WAS REPLACED IN THE PATIENT. THE EXTERNAL PACKAGE OF THE NEW PRODUCT WAS CHECKED PRIOR TO USE AND FOUND INTACT WITHOUT ANY ABNORMALITIES. HOWEVER ONCE AFTER THE EXTERNAL PACKAGE WAS OPENED, THE PIGTAIL COIL AT THE TIP OF THE URETERAL STENT WAS FOUND TO BE BROKEN. THE USER OPENED A NEW KIT OF STENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441221 ↗
• MalfunctionNov 7, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, PAIN AND DISCOMFORT, HYDRONEPHROSIS, INFECTION, AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760042 ↗
• InjuryNov 7, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT ENCRUSTATION, EDEMA, URETERAL REFLUX, PAIN, DISCOMFORT, HYDRONEPHROSIS, INFECTION, AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 12759716 ↗