Bard® InLay® Versa Fit® Ureteral Stent with NiCore™ Guidewire 776400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741014151), received between Jan 9, 2020 and Jun 12, 2023 — classified as 2 injuries.

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

• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED THAT THE PATIENT EXPERIENCED STONE FORMATION, URETERAL REFLUX, URETERAL EROSION PRIOR TO THE DEVICE PLACEMENT AND LOSS OF RENAL FUNCTION, URETERAL APERISTALSIS COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND STENT PLACEMENT WAS NEEDED FOR URETERAL APERISTALSIS IN RELATION TO INLAY VERSAFIT MULTI-LENGTH URETERAL STENT WITH NICORE NITINOL/NITINOL GUIDEWIRE 4.7FR 22CM-32CM. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 17107576 ↗
• InjuryJan 9, 2020Material Deformation; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INLAY STENT BECAME KNOTTED AT THE END OF THE PIGTAIL DURING USE IN THE PATIENT. THE PATIENT HAD TO BE ANAESTHETIZED FOR THE STENT TO BE REMOVED, AND EXPERIENCED SOME PAIN AFTER REMOVAL.

  Patient problems: No Code Available; Pain; Patient Problem/Medical Problem

  MAUDE report 9572127 ↗