Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776424Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801741014199), received between Jan 21, 2022 and Apr 4, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT IN CHART 3, IN THE ONLINE SURVEY A DR. IN QUESTION: "PLEASE SPECIFY IF ANY OF THE FOLLOWING ADVERSE EVENTS OCCURRED AS A RESULT OF THE DEVICE (I.E. PLEASE INDICATE IF THE PATIENT EXPERIENCED ANY DEVICE RELATED ADVERSE EVENTS). " SHE/HE ANSWERED THE FOLLOWING AES: CHART 3- URETERAL REFLUX, PAIN/DISCOMFORT, INFECTION, HEMATURIA. ALSO, THE RESPONDENT IN QUESTION "DID THE URETERAL REFLUX, PAIN/DISCOMFORT, INFECTION, HEMATURIA RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION? OF NOTE: ANY ACTION AS A RESULT OF AN ADVERSE EVENT IS CONSIDERED MEDICAL INTERVENTION (E.G. PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC.)" SHE/HE ANSWERED WITH "NO" IN ALL LOOPS. IN ADDITION, IN QUESTION "DID THE PATIENT EXPERIENCE ANY OF THE FOLLOWING COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF INLAY URETERAL STENT WITH NICORE GUIDEWIRE?" SHE/HE ANSWER WITH THE FOLLOWING COMPLICATIONS: URINARY SYMPTOMS, HEMATURIA. THE CODE OF PRODUCT IS CHART 3- 776424.

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

  MAUDE report 24785555 ↗
• InjuryJan 21, 2022Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED STONE FORMATION, URETERAL REFLUX, INFECTION, AND URINARY SYMPTOMS, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN

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

  MAUDE report 13314132 ↗
• MalfunctionJan 21, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE USER EXPERIENCED STONE FORMATION, URETERAL REFLUX, INFECTION AND URINARY SYMPTOMS, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314130 ↗
• MalfunctionJan 21, 2022Calcified; Calcified

  IT WAS REPORTED THAT THE USER EXPERIENCED STONE FORMATION AND STENT ENCRUSTATION, URETERAL REFLUX, INFECTION, AND URINARY SYMPTOMS, OCCLUSION WHILE USING THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314064 ↗