Bard® InLay® Ureteral Stent 778622Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741014819), received between May 23, 2023 and Mar 26, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
- Patient Device Interaction Problem1
Patient problems
- Discomfort1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT CRITICAL CARE NURSES REPORTED IN AN PMCF THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 778622 - INLAYTM URETERAL STENT WITHOUT GUIDEWIRE,6 FR.,22CM AND THE PATIENT EXPERIENCED PAIN, DISCOMFORT AND URINARY SYMPTOMS. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. THEY UTILIZED OXBUTYNIN AND FLOMAX TO HELP ALLEVIATE BLADDER SPASM RELATED PAIN FROM INDWELLING STENT AND AGAIN OXYBUTYNIN AND FLOMAX.
Patient problems: Discomfort; Pain; Unspecified Kidney or Urinary Problem
MAUDE report 18978164 ↗MalfunctionMay 23, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE PUSHER OF THE URETERAL STENT BROKE IN USE DURING PROCEDURE. THIS HAD HAPPENED 3 TIMES. THE PICTURES SHOWS THE LEAD MARKINGS LEFT BEHIND IN NEW REPELS AND WHERE ON THE PUSHER THE BREAK HAPPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16986388 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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