Bard® InLay Optima® Multilength Ureteral Stent with NiCore™ Guidewire 786600Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741015073), received between Mar 28, 2018 and Jul 25, 2025 — classified as 2 injuries, 7 malfunctions.

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

• MalfunctionJul 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, STENT WAS ALREADY BROKEN IN THE PACKAGE. THEY SAW THAT THE CURL WAS BROKEN OFF OF THE STENT. SO, IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608729 ↗
• InjuryFeb 19, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, OPTIMA WAS INSERTED IN AN EMERGENCY FOR CALCULOUS PYELONEPHRITIS. AFTER THE NEXT DAY, THE PATIENT EXPERIENCED HEMATURIA AND BACK PAIN, AND CT SCANS WERE TAKEN, AND IT SEEMS THAT THE TIP OF THE STENT WAS STRAYED INTO THE RENAL CORTEX. THE BACK PAIN WOULD NOT BE AFFECTED BY STENT. ON (B)(6) 2025, THE DOCTOR WAS CONTACTED AND TOLD THAT THE PATIENT HAD A COAGRA IN THE RENAL CORTEX AND HAD FEVER, SO CORRECTED OR REPLACED THE POSITION OF STENT FROM THEN.

  Patient problems: Hematuria; Pain

  MAUDE report 21410418 ↗
• MalfunctionDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE AFTER OPENING THE PRODUCT, THERE WERE CRACKS NEAR THE URETHRAL STENT PIGTAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036792 ↗
• MalfunctionMar 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE "786600 - INLAY OPTIMATM MULTI-LENGTH URETERAL STENT WITH NICORE¿ GUIDEWIRE, 6 FR., 22CM ¿ 32CM " AND THE PATIENT EXPERIENCED "PAIN OR DISCOMFORT" AND "URINARY SYMPTOMS". THIS DID NOT RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Discomfort; Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 18931490 ↗
• MalfunctionMar 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  CRITICAL CARE PHYSICIAN REPORTED IN A PMCF THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE "787624 - INLAY OPTIMATM URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE, 6.0 FR. X 24CM " AND THE PATIENT EXPERIENCED "PAIN OR DISCOMFORT". THIS DID NOT RESULT IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Discomfort; Pain

  MAUDE report 18913982 ↗
• MalfunctionMar 19, 2019Incorrect Measurement; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE STENT WAS LONGER THAN USUAL, AND AS A RESULT IT DID NOT CURL INTO THE PATIENT'S RENAL PELVIS; ALLEGEDLY THIS CAUSED A LOT OF DISCOMFORT AND PAIN. IT WAS ALSO REPORTED THAT THE STENT KNOTTED DUE TO THE INCREASED LENGTH. THE PHYSICIAN REPORTED THIS EVENT HAS OCCURRED WITH THE LAST 3 PATIENTS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2019 FROM IBC REPRESENTATIVE, ALL THREE PATIENTS ALLEGEDLY EXPERIENCED DISCOMFORT DUE TO THE LONGER STENT.

  Patient problems: Discomfort

  MAUDE report 8431860 ↗
• MalfunctionMar 18, 2019Material Integrity Problem

  IT WAS REPORTED THAT THE STENT WAS LONGER THAN USUAL. AS A RESULT IT DID NOT CURL NICELY INTO THE PATIENT'S RENAL PELVIS, ALLEGEDLY CAUSING A LOT OF DISCOMFORT AND PAIN. IT WAS ALSO REPORTED THAT THE STENT KNOTTED DUE TO THE INCREASED LENGTH. THE PHYSICIAN REPORTED THAT THE EVENT HAPPENED WITH THE LAST 3 PATIENTS.

  Patient problems: Discomfort; No Consequences Or Impact To Patient; Pain

  MAUDE report 8429671 ↗
• MalfunctionMar 18, 2019Incorrect Measurement; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE STENT WAS LONGER THAN USUAL. AS A RESULT, IT DID NOT CURL NICELY INTO THE PATIENT'S RENAL PELVIS, ALLEGEDLY CAUSING A LOT OF DISCOMFORT AND PAIN. IT WAS ALSO REPORTED THAT THE STENT KNOTTED DUE TO THE INCREASED LENGTH. THE PHYSICIAN REPORTED THAT THE EVENT HAD HAPPENED WITH THE LAST 3 PATIENTS.

  Patient problems: Discomfort; Pain

  MAUDE report 8429669 ↗
• InjuryMar 28, 2018Knotted

  IT WAS REPORTED THAT THE STENT WAS INSERTED INTO THE PATIENT; HOWEVER, THE STENT HAD A KNOT MID URETER. DR. (B)(6) SAW THE PATIENT AND DISCOVERED THE FAULTY STENT. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE STENT. A LAPAROSCOPIC PYELOPLASTY AND PYELOLITHOTOLY WAS PERFORMED TO REMOVE THE STENT.

  Patient problems: Injury; No Code Available

  MAUDE report 7378397 ↗