Bard® InLay Optima® Ureteral Stent 788726Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741015847), received between Dec 15, 2020 and Feb 10, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE GUIDEWIRE WAS ENTANGLEMENT DURING STENT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308752 ↗
• MalfunctionDec 5, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE CUSTOMER IMPLANTED URETERAL STENT 788726 INTO A PATIENT. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2025, FOR STENT REMOVAL. THE PROCEDURE PROVED DIFFICULT DURING EXTRACTION, AND UPON REMOVAL, THE STENT WAS FOUND COMPLETELY ENCRUSTED WITH STONES. THE CUSTOMER BELIEVED THAT THE STENT BECAME COMPLETELY ENCRUSTED WITH STONES WITHIN LESS THAN TWO MONTHS OF PLACEMENT CONTRADICTS THE LONG TERM RETENTION CAPABILITY PROMISED IN THEIR PRODUCT DOCUMENTATION. CONSEQUENTLY, THE CUSTOMER SUSPECTS A PRODUCT QUALITY ISSUE AND HAD FILED A COMPLAINT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23729564 ↗
• MalfunctionJul 21, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT URETERAL STENT SNAGGED WITH GUIDEWIRE (150NSS35) DURING STENT PLACEMENT AND COULD NOT BE PLACED SMOOTHLY, SUTURE REMOVED. A NEW STENT WAS OPENED FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554340 ↗
• MalfunctionDec 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING URETEROSCOPIC LITHOTRIPSY ON (B)(6) 2024, THE DOCTOR OPENED THE PACKAGE AND FOUND THAT THE END OF THE SILK THREAD OF THE STENT WAS BROKEN, AND 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 21011812 ↗
• MalfunctionNov 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT WAS BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772177 ↗
• MalfunctionJul 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE STENT WAS CREASED AND COULD NOT BE USED. THE SILK THREAD WAS NOT REMOVED, AND THE STENT DID NOT ENTER THE HUMAN BODY. OPEN A NEW STENT FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781747 ↗
• MalfunctionMar 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NURSE IN THE OPERATING ROOM DID NOT REALIZE THE ABNORMALITY OF THE STENT WHEN UNPACKING IT AT THE FIRST TIME, SO THE NURSE CUT THE WIRE AT THE END OF THE STENT AS USUAL TO PREPARE FOR SURGICAL IMPLANTATION. ONLY WHEN THE SURGEON IMPLANTED AND PUSHED THE STENT LATER, THEY FOUND THAT THE MIDDLE OF THE STENT WAS BROKEN AND REMOVED. A NEW STENT IMPLANTED INTO THE PATIENT'S BODY. THIS QUALITY INCIDENT DID NOT HAVE ANY ADVERSE EFFECTS ON THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985843 ↗
• MalfunctionApr 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOUBLE J URETERAL STENT WAS BROKEN AT THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723822 ↗
• MalfunctionApr 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOUBLE J URETERAL STENT WAS BROKEN AT THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723815 ↗
• MalfunctionMay 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE BROKEN AND THE COIL SEPARATED WITH THE STRAIGHT SITE AFTER OPENING THE PACKAGE. IT WAS STATED THAT THE USER USED ANOTHER NEW INLAY. PER NOTIFICATION FROM INVESTIGATOR ON 08NOV2021, IT WAS REPORTED THAT THE RETURNED STENT SAMPLE WAS FOUND WITH DIFFERENT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14363761 ↗
• MalfunctionDec 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE USER EXPERIENCED URETERAL REFLUX, PAIN OR DISCOMFORT, URINARY SYMPTOMS, STENT DISLODGEMENT, MIGRATION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981419 ↗
• MalfunctionDec 10, 2021Migration; Migration

  IT WAS REPORTED THAT THE USER EXPERIENCED URETERAL REFLUX, PAIN OR DISCOMFORT, URINARY SYMPTOMS, STENT DISLODGEMENT, MIGRATION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981418 ↗
• MalfunctionDec 10, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE USER EXPERIENCED URETERAL REFLUX, PAIN OR DISCOMFORT, URINARY SYMPTOMS, STENT DISLODGEMENT, MIGRATION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981417 ↗
• MalfunctionDec 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THERE WAS A FRACTURE ON THE STENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 18NOV2021, PATIENT STATED THAT THEY NOTICED THE FRACTURE UPON OPENING THE PACKAGE AND IT WAS UNKNOWN HOW THE FRACTURE OCCURRED. NO INFORMATION REGARDING ANY DAMAGE ON THE OUTER BOX. IT WAS NOT USED ON THE PATIENT AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951575 ↗
• MalfunctionApr 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE BROKEN AND THE COIL SEPARATED WITH THE STRAIGHT SITE AFTER OPENING THE PACKAGE. IT WAS STATED THAT THE USER USED ANOTHER NEW INLAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700918 ↗
• MalfunctionJan 5, 2021Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT WHEN THE DOCTOR WANTED TO PLACE THE STENT AND HE STRETCHED THE PIGTAIL ON BLADDER SIDE AND THE PIGTAIL RIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11118625 ↗
• MalfunctionDec 15, 2020Accessory Incompatible; Nonstandard Device; Accessory Incompatible; Nonstandard Device

  IT WAS REPORTED THAT AS THE PIGTAIL OF THE INLAY OPTIMA WAS NOT ROLLED UP, THE SURGEON COULD NOT INSERT IT INTO THE URETER. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 26NOV2020, PIGITAL SHAPE OF THE STENT NOT ROLLED UP LIKE HOW IT IS SUPPOSED TO LOOKS ORIGINALLY. DEFECTIVE DEVICE NOTICE ONCE IT IS OUT FROM PACKAGING. THEREFORE THIS IS NOT USED IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11008917 ↗