Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776724Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801741014335), received between Oct 26, 2021 and Nov 2, 2021 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRO NEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737743 ↗
• MalfunctionOct 28, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711588 ↗
• InjuryOct 27, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRO NEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Fistula

  MAUDE report 12706366 ↗
• MalfunctionOct 27, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706319 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRO NEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETERAL REFLUX.

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

  MAUDE report 12698838 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRO NEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 12698836 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRO NEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 12698819 ↗
• MalfunctionOct 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION HEMORRHAGE, STENT ENCRUSTATION , HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698818 ↗
• InjuryOct 26, 2021Calcified; Biocompatibility; Calcified; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification

  MAUDE report 12698815 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER.

  Patient problems: Internal Organ Perforation

  MAUDE report 12698609 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETERAL EROSION.

  Patient problems: Erosion

  MAUDE report 12698583 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION

  Patient problems: Unspecified Infection

  MAUDE report 12698563 ↗
• MalfunctionOct 26, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698487 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR HYDRONEPHROSIS

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

  MAUDE report 12698481 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12698473 ↗
• InjuryOct 26, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EDEMA, STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT, MIGRATION, FRAGMENTATION, OCCLUSION, FISTULA FORMATION, LOSS OF RENAL FUNCTION, HEMORRHAGE, STENT ENCRUSTATION, HYDRONEPHROSIS, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND BLADDER, URETERAL EROSION, INFECTION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENT. UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 12698361 ↗