Bard® InLay Optima® Ureteral Stent with NiCore™ Guidewire 786726Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801741015202), received between Mar 8, 2021 and Sep 24, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Calcified” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT UNDERWENT THE RIGHT FLEXIBLE URETEROSCOPE AND REQUIRED TO HAVE A URETERAL STENT. UPON OPENING OF THE PACKAGE OF ONE SUCH STENT, THE NURSE FOUND THAT IT WAS RUPTURED. THE CATHETER WAS REINSERTED TO COPE WITH THE INJURY TO THE URETER CAUSED BY CATHETER REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 19-SEP-2022, PRODUCT WAS NOT USED ON THE PATIENT SO NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477226 ↗
• InjuryNov 9, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URETERAL EROSION WHILE USING URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETERAL EROSION.

  Patient problems: Erosion

  MAUDE report 12782753 ↗
• MalfunctionMay 10, 2021Calcified; Calcified

  IT WAS REPORTED THAT PATIENT RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN AND FOUND THE STENT TO BE ENCRUSTED IN LESS THAN SIX MONTHS. THE DOCTOR STATED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS. ALSO, STATED THAT THIS HAD HAPPENED TO MINIMUM OF 10 PATIENTS AND STENT WAS BEING REMOVED. PER FOLLOW UP VIA IBC ON 03MAY2021, THE PATIENTS EXPERIENCED SYMPTOMS LIKE PAIN, URGE TO URINATE, HEMATURIA, URGENT RETRIEVAL OF THE STENT IN THE OPERATION ROOM (OR). THEREFORE, PLACED ANOTHER STENT FROM ANOTHER BRAND. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 11801927 ↗
• MalfunctionMay 4, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS, THE DOCTOR SAW PATIENTS WHO RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN WAS FOUND WITH STENT ENCRUSTED IN LESS THAN 06 MONTHS. ALSO STATED THIS HAPPENED TO MINIMUM 10 PATIENTS AND STENT WAS BEING REMOVED.

  Patient problems: Hematuria; Micturition Urgency; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11768988 ↗
• MalfunctionMay 3, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS, THE DOCTOR SAW PATIENTS WHO RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN WERE FOUND WITH STENT ENCRUSTED IN LESS THAN 06 MONTHS. ALSO STATED THIS HAPPENED TO MINIMUM 10 PATIENTS AND STENT WAS BEING REMOVED. PER FOLLOW UP VIA IBC ON 03MAY2021, THE PATIENTS EXPERIENCED SYMPTOMS LIKE PAIN, URGE TO URINATE, HEMATURIA, URGENT RETRIEVAL OF THE STENT IN THE OPERATION ROOM (OR). THEREFORE, PLACED ANOTHER STENT FROM ANOTHER BRAND. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hematuria; Micturition Urgency; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11760246 ↗
• InjuryMar 8, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS. THE DOCTOR OBSERVED PATIENTS WHO RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN AND WAS FOUND WITH STENT ENCRUSTED IN LESS THAN 06 MONTHS. ALSO STATED THIS HAPPENED TO MINIMUM 10 PATIENTS. PER FOLLOW UP VIA IBC ON 18FEB2021, THE PATIENT EXPERIENCED SYMPTOMS LIKE PAIN, URGE TO URINATE AND HEMATURIA AND HENCE, THE URGENT RETRIEVAL OF THE STENT WAS UNDERGONE IN OPERATION ROOM (OP) AND PLACED ANOTHER STENT FROM ANOTHER BRAND.

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

  MAUDE report 11441153 ↗