Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776626Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10801741014274), received between Oct 28, 2021 and Jan 22, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Calcified” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Calcified

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT URETEROSCOPIC LASER LITHOTRIPSY AND LEFT URETERAL STENT PLACEMENT. THE PROCEDURE WAS SMOOTH, AND THE INTERNAL STENT DRAINED WELL. ONE MONTH LATER, THE PATIENT RETURNED AS INSTRUCTED FOR PLANNED STENT REMOVAL. INTRAOPERATIVELY, A LARGE AMOUNT OF STONE ADHERED TO THE ENTIRE SURFACE OF THE RENAL PELVIC END OF THE URETERAL STENT, PREVENTING ITS REMOVAL. HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE MOST OF THE STONES ON THE URETERAL STENT, AND THE STENT WAS COMPLETELY REMOVED FROM THE URETER USING FOREIGN BODY FORCEPS.

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

  MAUDE report 24157803 ↗
• InjuryDec 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT LASER LITHOTRIPSY AND LEFT URETERAL STENT PLACEMENT. THE PROCEDURE WAS SUCCESSFUL, AND THE STENT DRAINAGE WAS UNOBSTRUCTED. ONE MONTH LATER, THE PATIENT RETURNED TO THE HOSPITAL AS INSTRUCTED FOR STENT REMOVAL. DURING THE PROCEDURE, NUMEROUS STONES WERE FOUND ADHERING TO THE ENTIRE SURFACE OF THE STENT, MAKING REMOVAL DIFFICULT. HOLMIUM LASER LITHOTRIPSY SURGERY WAS PERFORMED TO REMOVE MOST OF THE STONES FROM THE URETERAL STENT, AND THE STENT WAS COMPLETELY REMOVED FROM THE URETER USING FOREIGN BODY FORCEPS. PATIENT BEEN EXPOSED TO HAZARDOUS SUBSTANCES, BLOOD, OR BODILY FLUIDS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Exposure to Body Fluids

  MAUDE report 23717297 ↗
• InjuryDec 4, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT NEPHROLITHOTRIPSY WITH HOLMIUM LASER LITHOTRIPSY VIA URETEROSCOPE AND RIGHT URETERAL STENT PLACEMENT. A URETERAL STENT WAS PLACED INTRAOPERATIVELY. THE PROCEDURE PROCEEDED SMOOTHLY WITH UNOBSTRUCTED DRAINAGE. ONE MONTH LATER, THE PATIENT RETURNED AS INSTRUCTED FOR URETERAL STENT REMOVAL. INTRAOPERATIVELY, EXTENSIVE CALCULUS ADHESION WAS OBSERVED ON THE STENT SURFACE. HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE THE URETERAL STONES AND EXTRACT THE STENT, RESULTING IN BLEEDING. SOLUTION: HOLMIUM LASER LITHOTRIPSY WAS PERFORMED TO REMOVE MOST OF THE STONES ADHERING TO THE URETERAL STENT. THE INTACT STENT WAS THEN EXTRACTED USING FOREIGN BODY FORCEPS. SURGICAL INTERVENTION WAS PERFORMED.

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

  MAUDE report 23717293 ↗
• MalfunctionJun 17, 2024Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT THE URETERAL STENT WAS READY FOR IMPLANTATION. THE USER PULLED THE WIRE TOO HARD, CAUSING THE STENT RING TO BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546975 ↗
• InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CRITICAL CARE NURSES REPORTED IN AN PMCF THAT THE PATIENT ADMITTED FOR STENT REMOVAL EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 776626 - INLAYTM URETERAL STENT WITH NICORE NITINOL/NITINOL GUIDEWIRE,6 FR.,26CM AND THE PATIENT EXPERIENCED URINARY SYMPTOMS. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 18977980 ↗
• MalfunctionApr 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN DELIVERING THE URETERAL STENT DURING OPERATION, THE STENT COULD NOT BE ENTERED. ANOTHER KIT WAS UNPACKED SUBSEQUENTLY AND THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732518 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND STENT ENCRUSTATION WHILE USING THE URETERAL STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748762 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN ASKED FOR COMPLICATIONS WHILE USING URETERAL STENT, THE USER MENTIONED: STENT DISLODGEMENT, MIGRATION, PAIN AND DISCOMFORT, INFECTION, URINARY SYMPTOMS. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748759 ↗
• MalfunctionNov 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS: STENT DISLODGEMENT, MIGRATION, PAIN AND DISCOMFORT, INFECTION, URINARY SYMPTOMS WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747020 ↗
• InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS: STENT DISLODGEMENT, MIGRATION, PAIN AND DISCOMFORT, INFECTION, URINARY SYMPTOMS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 12746032 ↗
• InjuryNov 3, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED STENT ENCRUSTATION AND PAIN, DISCOMFORT AND INFECTION BY URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 12745445 ↗
• MalfunctionNov 3, 2021Calcified; Calcified

  IT WAS REPORTED THAT PATIENT EXPERIENCED STENT ENCRUSTATION AND PAIN, DISCOMFORT AND INFECTION BY URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745348 ↗
• MalfunctionNov 3, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION, AND STENT ENCRUSTATION WHILE USING URETERAL STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745240 ↗
• MalfunctionNov 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND STENT ENCRUSTATION WHILE USING URETERAL STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745145 ↗
• MalfunctionOct 28, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED OCCLUSION, URINARY SYMPTOMS, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711589 ↗