Bard® InLay Optima® Ureteral Stent with NiCore™ Guidewire 786624Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801741015110), received between Feb 7, 2020 and Jun 16, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Calcified

  It was reported that the patient had the Ureteral stent in place for less than two months, and severe stone encrustation was found, so the stent was removed and a new stent was implanted. The user was exposed to hazardous substances, blood, or body fluids.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521767 ↗
• MalfunctionJul 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, THERE WAS A SPLIT IN THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554317 ↗
• MalfunctionJul 21, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, WHEN THE URETHRAL STENT PACKAGE WAS OPENED DURING THE OPERATION AND READY FOR PLACEMENT, IT WAS FOUND THAT THE DRAINAGE HOLE ON THE HEAD OF THE URETERAL STENT WAS BROKEN, AND THE STENT HAD BEEN REPLACED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553994 ↗
• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE STENT PACKAGE WAS OPENED DURING THE OPERATION AND READY FOR PLACEMENT, IT WAS FOUND THAT THE DRAINAGE HOLE ON THE HEAD OF THE URETERAL STENT WAS BROKEN, AND THE STENT WAS REPLACED DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384677 ↗
• MalfunctionJul 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE URETHRAL STENT WAS DISASSEMBLED TO CUT THE SUTURE AND INSPECTED BEFORE BEING PLACED IN THE STENT, IT WAS FOUND THAT THE STENT HAD OBVIOUS CUT MARKS AND COULD NOT BE USED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373435 ↗
• MalfunctionJun 12, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT BEFORE USE, CUSTOMER NOTICED 786624 DID NOT HAVE A STENT IN THE BOX. BOX HAD 2 GUIDE WIRES INSTEAD OF A STENT AND A GUIDE WIRE. STENT BOX HAD 2 GUIDE WIRES AND NO STENT, CUSTOMER COULD NOT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194178 ↗
• MalfunctionJun 4, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN UNPACKED THE PACKAGE, CUT THE SILK THREAD, STRAIGHTEN THE PIG'S TAIL, AND WHEN THE PIG'S TAIL STRAIGHTENER WAS TAKEN OUT, THE STENT BROKE FROM THE DRAINAGE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460788 ↗
• MalfunctionJul 10, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE GUIDEWIRE ACCESSORIES WERE FOUND TO BE MISSING WHEN THE PACKAGE WAS OPENED BEFORE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289173 ↗
• MalfunctionAug 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ONE DRAINAGE HOLE IN THE URETERAL STENT WAS FOUND TO BE BENT UPON OPENING OF THE PACKAGE. IT WAS IMPOSSIBLE TO INSERT THE GUIDEWIRE AFTER MULTIPLE ATTEMPTS AND THE GUIDEWIRE COULD NOT BE PASSED THROUGH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, IT WAS STATED THAT THE URETERAL STENT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190802 ↗
• InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 12746680 ↗
• MalfunctionJun 28, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT ONLY A GUIDE WIRE WAS SEEN INSIDE WITHOUT ANY STENT AFTER THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080650 ↗
• MalfunctionFeb 7, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE URETERAL STENT DEVELOPED SEVERE OCCLUSIONS.

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

  MAUDE report 9682112 ↗