Bard® InLay® Ureteral Stent 778624Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741014826), received between Apr 16, 2018 and Sep 24, 2025 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT STENT PUSHER KINKING BEFORE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137478 ↗
• MalfunctionJun 25, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, THE PUSHER OF THE URETERAL STENT WAS KINKING BEFORE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327622 ↗
• MalfunctionNov 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT URETERAL STENT BROKE AFTER IT WAS PLACED IN THE PATIENT. NO IMPACT TO PATIENT. THEY REMOVED THE STENT AND PLACED A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073798 ↗
• MalfunctionSep 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CONDUIT LINE OF THE URETERAL STENT WAS BROKEN. IT WAS STATED THAT THE CONDUIT LINE WAS BROKEN AND THEN ENDED AT THE HORIZONTAL BAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798171 ↗
• MalfunctionJul 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THEY SHOULD OPEN THE GUIDE WIRE PACKAGE IF THE CONTENT WAS A BROKEN TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312950 ↗
• MalfunctionDec 20, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DOCTOR WAS PLACING AN 6FR INLAY URETERAL STENT AFTER A URETEROSCOPY, BUT THE STENT WOULD NOT ADVANCE OVER A SOLO FLEX 0.38 GUIDEWIRE. AFTER OPENING ANOTHER 6FR INLAY URETERAL STENT, THE DOCTOR WAS EASILY ABLE TO BACKLOAD THE STENT INTO THE PATIENT OVER THE SAME SOLO FLEX 0.38 GUIDEWIRE. THE DETERMINATION WAS THAT THE STENT WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014015 ↗
• MalfunctionAug 8, 2022Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT DOUBLE J STENT BROKE THE TUBE WHILE REMOVING THE BLACK WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183547 ↗
• MalfunctionNov 22, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE URETHRAL STENT WAS BROKEN UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12855091 ↗
• InjuryNov 4, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION, URETERAL REFLUX ,INFECTION, URINARY SYMPTOMS, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URETERAL REFLUX ,INFECTION, URINARY SYMPTOMS, PAIN AND DISCOMFORT.

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

  MAUDE report 12751220 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748949 ↗
• MalfunctionNov 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION, URETERAL REFLUX, INFECTION, URINARY SYMPTOMS, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748938 ↗
• MalfunctionNov 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION, URETERAL REFLUX ,INFECTION, URINARY SYMPTOMS, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746886 ↗
• MalfunctionNov 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STENT DISLODGEMENT, MIGRATION AND URINARY SYMPTOMS WHILE USING THE BARD URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745940 ↗
• MalfunctionJul 28, 2021Material Fragmentation; Component Missing; Material Fragmentation; Component Missing

  IT WAS REPORTED THAT THE DEVICE WAS MISSING ONE END PIGTAIL WHEN OPENED THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239195 ↗
• MalfunctionMar 12, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE PIGTAIL WAS BROKEN OFF. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 22FEB2021, THE DEVICE WAS NOT USED ON PATIENT HENCE THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476011 ↗
• InjuryJan 8, 2021Incorrect Measurement; Biocompatibility; Incorrect Measurement; Biocompatibility

  IT WAS REPORTED THAT THE STRING OF THE URETERAL STENT SEEMED TO BE BIT THICKER THAN NORMAL AND IT DID NOT MOVE VERY WELL THROUGH THE CYSTOSCOPE. WHILE THE SURGEON WAS ATTEMPTING TO PLACE IT, THE STRING TUGGED AND TANGLED SO THE ENTIRE STENT WAS REMOVED. HENCE THE STRING COULD BE CUT OFF AND THE STENT COULD BE REPLACED. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 22DEC2020 THE STENT WAS REMOVED AND THE STRING HAD TO BE CUT WHICH RESULTED IN AN ADDITIONAL PROCEDURE FOR THE PATIENT TO HAVE IT REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11141002 ↗
• InjuryJan 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE STRING OF URETHRAL STENT SEEMED TO BE BIT THICKER THAN NORMAL AND IT DID NOT MOVE VERY WELL THROUGH THE CYSTOSCOPE. WHILE THE SURGEON WAS ATTEMPTING TO PLACE IT, THE STRING TUGGED AND TANGLED. SO, THE ENTIRE STENT HAD TO BE REMOVED. HENCE, THE STRING COULD BE CUT OFF AND THE STENT COULD BE REPLACED. PER FOLLOW UP RESPONSE RECEIVED VIA MAIL ON (B)(6)2020, THE STENT WAS REMOVED AND THE STRING HAD TO BE CUT, WHICH RESULTED IN AN ADDITIONAL PROCEDURE FOR THE PATIENT TO HAVE IT REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11140997 ↗
• InjuryNov 9, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URTICARIA AND HIVES WITH URETHRAL STENT. AS PER THE FOLLOW UP, THE STENT WAS IN PLACE FOR 2 DAYS BEFORE THE SYMPTOMS STARTED. THE STENT IS REPORTEDLY STILL IN PLACE. THE PATIENT WAS TREATED WITH ANTIHISTAMINES SUCH AS HYDROXYZINE.

  Patient problems: Irritation; Skin Inflammation/ Irritation

  MAUDE report 10813539 ↗
• InjuryOct 29, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URTICARIA WITH THE BARD INLAY URETERAL STENT. THE URTICARIA WAS RED AND EXPERIENCED ITCHY SKIN RASH THAT OCCURS ON THE ENTIRE BODY FOR THREE WEEKS AND THE KIDNEY STENT, WHICH WAS PLACED 2 DAYS BEFORE THE SYMPTOMS BEGAN. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS GIVEN TO URTICARIA.

  Patient problems: Skin Inflammation

  MAUDE report 10755738 ↗
• InjuryDec 26, 2019Material Twisted/Bent; Break; Difficult to Remove; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A OPEN LAPAROTOMY PROCEDURE, A BARD URETERAL STENT WAS PLACED WITH A BOSTON SCIENTIFIC GUIDEWIRE. THE UROLOGIST PASSED THE GUIDEWIRE UP THE URETER THEN PLACED THE STENT. UPON REMOVAL THE BOSTON SCIENTIFIC GUIDEWIRE BROKE AND UNRAVELED. AN X-RAY WAS PERFORMED, AND IT SHOWED NO FOREIGN BODY IN THE AREA. HOWEVER, POST EVALUATION SHOWED THE PROXIMAL END OF THE STENT WAS BENT OVER IN ITSELF. THE STENT NEEDED TO BE REMOVED AT A LATER DATE WITH A POSSIBLE REPLACEMENT NEEDED IN 6-12 WEEKS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9519420 ↗
• MalfunctionNov 13, 2019Break

  IT WAS REPORTED THAT THE ORANGE PUSHER TIP BROKE OFF INSIDE OF THE PATIENT. MEDICAL STAFF RETRIEVED THE BROKEN PIECE WITH GRASPER, AND THERE WAS NO INJURY TO PATIENT.

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

  MAUDE report 9318260 ↗
• MalfunctionApr 16, 2018Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN.

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

  MAUDE report 7434469 ↗