Bard® Silicone Uretero-Intestinal Anastomosis Urinary Diversion Stent 089007Recalls & reported problems
C. R. Bard, Inc. · Bard® Silicone Uretero-Intestinal Anastomosis Urinary Diversion Stent with Hydro-Glide™ Guidewire · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard silicone urinary diversion stent is implanted surgically to carry urine away from the bowel after the bladder is removed or bypassed. The 34 reports filed between April 2022 and September 2022 mostly describe the stent not draining urine as expected, becoming encrusted with mineral deposits, or shifting and coming loose, along with infections of the urinary tract and the surgical incision, urgency, burning urination and blood in the urine. These reports include 17 injuries and 17 malfunctions, with no deaths mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10801741011648), received between Apr 7, 2022 and Sep 16, 2022 — classified as 17 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (5 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
- Adverse Event Without Identified Device or Use Problem17
- Inaccurate Flow Rate5
- Migration5
- Calcified4
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Urinary Tract Infection12
- Post Operative Wound Infection8
- Micturition Urgency6
- Dysuria4
- Hematuria4
- Unspecified Kidney or Urinary Problem3
- Urinary Retention3
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT DYSURIA, SURGICAL SITE INFECTION, URINARY TRACT INFECTION AND IRRITATIVE URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Dysuria; Post Operative Wound Infection; Urinary Tract Infection
MAUDE report 15437275 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URGENCY, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND INCOMPLETE EMPTYING WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Micturition Urgency; Unspecified Kidney or Urinary Problem; Urinary Tract Infection
MAUDE report 15437272 ↗MalfunctionSep 15, 2022Migration; Migration
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT INCOMPLETE EMPTYING, STENT MIGRATION, STENT ENCRUSTATION, SURGICAL SITE INFECTION AND DISLODGMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427709 ↗MalfunctionSep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT INCOMPLETE EMPTYING, STENT MIGRATION, STENT ENCRUSTATION, SURGICAL SITE INFECTION AND DISLODGEMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427595 ↗MalfunctionSep 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URGENCY, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND INCOMPLETE EMPTYING WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Urinary Retention
MAUDE report 15427355 ↗MalfunctionSep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT DYSURIA, HEMATURIA, SURGICAL SITE INFECTION, INCOMPLETE EMPTYING AND DISLODGMENT WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15427219 ↗MalfunctionSep 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT DYSURIA, HEMATURIA, SURGICAL SITE INFECTION, INCOMPLETE EMPTYING AND DISLODGMENT WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: Urinary Retention
MAUDE report 15426967 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URGENCY, INCONTINENCE, URINARY TRACT INFECTION, AND IRRITATIVE URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS EXPERIENCED WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Incontinence; Micturition Urgency; Urinary Tract Infection
MAUDE report 15426958 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT INCOMPLETE EMPTYING , STENT MIGRATION , STENT ENCRUSTATION, SURGICAL SITE INFECTION AND DISLODGMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Post Operative Wound Infection
MAUDE report 15426867 ↗MalfunctionSep 15, 2022Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT INCOMPLETE EMPTYING , STENT MIGRATION , STENT ENCRUSTATION, SURGICAL SITE INFECTION AND DISLODGMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: Urinary Retention
MAUDE report 15426839 ↗MalfunctionSep 15, 2022Calcified; Calcified
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT INCOMPLETE EMPTYING, STENT MIGRATION, STENT ENCRUSTATION, SURGICAL SITE INFECTION AND DISLODGMENT WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15426831 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT DYSURIA, HEMATURIA, SURGICAL SITE INFECTION, INCOMPLETE EMPTYING AND DISLODGMENT WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Dysuria; Hematuria; Post Operative Wound Infection
MAUDE report 15426684 ↗InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT DISLODGMENT AND URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS FACED WHILE USING THE URETHRAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 14207089 ↗MalfunctionApr 25, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT SURVEY RESPONDENT MENTIONED ABOUT DISLODGMENT AND URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14192502 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER MENTIONED INCOMPLETE EMPTYING, STENT ENCRUSTATION AND SURGICAL SITE INFECTION WHEN ASKED ABOUT THE COMPLICATIONS WHILE USING THE URINARY STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Post Operative Wound Infection
MAUDE report 14163283 ↗MalfunctionApr 20, 2022Calcified; Calcified
IT WAS REPORTED THAT THE CUSTOMER MENTIONED INCOMPLETE EMPTYING, STENT ENCRUSTATION AND SURGICAL SITE INFECTION WHEN ASKED ABOUT THE COMPLICATIONS WHILE USING THE URINARY STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14162948 ↗MalfunctionApr 20, 2022Migration; Migration
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URGENCY, HEMATURIA, SURGICAL SITE INFECTION AND DISLODGMENT WHEN ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE URINARY STENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14161654 ↗MalfunctionApr 20, 2022Calcified; Calcified
IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT STENT MIGRATION, STENT ENCRUSTATION AND IRRITATIVE URINARY SYMPTOMS WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE URETHRAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14161653 ↗MalfunctionApr 20, 2022Migration; Migration
IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT URGENCY, INCONTINENCE, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND STENT MIGRATION WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE URETHRAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14161578 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CUSTOMER MENTIONED ABOUT URGENCY, INCONTINENCE, HEMATURIA, URINARY TRACT INFECTION, IRRITATIVE URINARY SYMPTOMS AND STENT MIGRATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Incontinence; Micturition Urgency; Urinary Tract Infection
MAUDE report 14161177 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CUSTOMER MENTIONED ABOUT URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 14161172 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URINARY URGENCY, DYSURIA, SUPRAPUBIC PAIN, SURGICAL SITE INFECTION, AND URINARY TRACT INFECTION WHEN ASKED OF COMPLICATIONS FACED WHILE USING THE URINARY STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Dysuria; Micturition Urgency; Pain; Post Operative Wound Infection; Urinary Tract Infection
MAUDE report 14161086 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT SURGICAL SITE INFECTION AND IRRITATIVE URINARY SYMPTOMS WHEN ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE URINARY STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Post Operative Wound Infection; Unspecified Kidney or Urinary Problem
MAUDE report 14160975 ↗InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT URGENCY, HEMATURIA, SURGICAL SITE INFECTION AND DISLODGMENT WHEN ASKED OF COMPLICATIONS FACED WHILE USING THE URINARY STENT. MEDICAL INTERVENTION WAS UNKNOWN.
Patient problems: Hematuria; Micturition Urgency; Post Operative Wound Infection
MAUDE report 14160970 ↗MalfunctionApr 20, 2022Migration; Migration
IT WAS REPORTED THAT CUSTOMER MENTIONED ABOUT STENT MIGRATION, STENT ENCRUSTATION AND IRRITATIVE URINARY SYMPTOMS WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160701 ↗
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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