Bard® InLay® Ureteral Stent with NiCore™ Guidewire 776428Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801741014212), received between May 10, 2022 and Apr 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Calcified” (1 report).

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.

• MalfunctionApr 9, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY, AND THEY STATED THAT IN CHARTS 3 AND 4, IN THE ONLINE SURVEY A DR. IN QUESTION: "DO YOU BELIEVE THE BENEFITS OF USING THE INLAY AND INLAY VERSAFIT URETERAL STENTS OUTWEIGH THE POTENTIAL RISKS (I.E. DO THE PROS OUTWEIGH THE CONS)?" SHE OR HE ANSWERED "NO, THE BENEFITS OF USING THIS PRODUCT DO NOT OUTWEIGH THE POTENTIAL RISKS.¿ BECAUSE "WHILE THE PRODUCT OFFERS SEVERAL BENEFITS, THERE ARE SOME POTENTIAL RISKS THAT REQUIRE CONSIDERATION. THE RISKS INCLUDE DATA PRIVACY CONCERNS, LEARNING CURVE FOR NEW USERS, AND POTENTIAL INTEGRATION CHALLENGES WITH EXISTING SYSTEMS. ADDITIONALLY, THERE MAY BE COST BENEFIT CONSIDERATIONS THAT NEED TO BE WEIGHED MORE CAREFULLY IN CERTAIN USE CASES. ", ALSO, IN CHARTS 3 AND 5 IN THE ONLINE SURVEY IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE OR HE ANSWERED "NO¿ BECAUSE "TOO SMALL " IN BOTH CHARTS. IN CHART 5 IN THE ONLINE SURVEY A IN QUESTION: "DID THE GUIDEWIRE SUPPORT STENT PLACEMENT PROCEDURE? SHE OR HE ANSWERED "NO¿ BECAUSE "DOESN'T FIT " THE CODE OF PRODUCT IS CHART 3 777400 AND CHART 5 776428.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832438 ↗
• MalfunctionApr 15, 2024Calcified; Calcified

  CRITICAL CARE NURSES REPORTED IN A PMCF A PHYSICIAN STATED THAT THEIR PATIENT EXPERIENCED STENT ENCRUSTATION AFTER PLACEMENT OF THE DEVICE. THE RESPONDENT INDICATED THEY BELIEVED THE COMPLICATION TO BE A PROCEDURE RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106197 ↗
• MalfunctionMar 29, 2024Complete Blockage; Complete Blockage

  CRITICAL CARE PHYSICIAN REPORTED IN A PMCF THAT STENT WAS NOT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE BECAUSE "THE SPLINT OCCLUDED DURING THE PERIOPERATIVE PERIOD" IN RELATION TO "776428 - INLAYTM URETERAL STENT WITH NICORE NITINOL/NITINOL GUIDEWIRE,4.7 FR.,28CM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007106 ↗
• MalfunctionMay 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT GOT BROKEN IN TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346049 ↗