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Bard® InLay® Ureteral Stent 778726Recalls & reported problems

C. R. Bard, Inc. · INLAY URETERAL STENT w/o GUIDEWIRE · Class 2 · Implant

All models of Bard InLay Ureteral Stent (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741014901), received between Nov 20, 2017 and Jun 12, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break2
  • Adverse Event Without Identified Device or Use Problem1
  • Detachment Of Device Component1
  • Material Fragmentation1
  • Material Rupture1
  • Missing Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement1
  • Unspecified Infection1
  • Urinary Tract Infection1

Recent adverse event reports

The 5 most recent of 5 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 PATIENT EXPERIENCED HEMATURIA PRIOR TO THE DEVICE PLACEMENT, INFECTION, URINARY SYMPTOMS COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND ANTIBIOTICS WAS NEEDED IN RELATION TO URETERAL STENT WITHOUT GUIDEWIRE.

    Patient problems: Unspecified Infection; Urinary Tract Infection

    MAUDE report 17106040 ↗
  • MalfunctionMay 31, 2023Missing Information; Missing Information

    IT WAS REPORTED THAT THE STENT (MATERIAL #778726) AND GUIDEWIRE (MATERIAL # HW35SA) HAD NO INFORMATION ON BOX OR PRODUCT INSIDE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17029937 ↗
  • MalfunctionApr 6, 2023Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT URETERAL STENT WAS FOUND TO BE RUPTURED WHEN THE USER WAS BEGINNING TO INSERT THE STENT DURING OPERATION ONCE THE PACKAGE WAS OPENED. THE STENT WAS NOT USED, CAUSING NO ADVERSE IMPACT ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16691175 ↗
  • MalfunctionJul 1, 2019Break; Break; Material Rupture

    IT WAS REPORTED THAT THE URETERAL STENT WAS FOUND RUPTURED WHEN PREPARED FOR USE.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 8748194 ↗
  • MalfunctionNov 20, 2017Break; Detachment Of Device Component

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT BROKE OFF AT THE END. THERE WAS NO REPORTED IMPACT TO THE PROCEDURE OR PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7045026 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

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