Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777428Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741014496), received between Feb 26, 2018 and Jun 9, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Calcified; Calcified

  IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, INFECTION, HEMATURIA PRIOR TO THE DEVICE PLACEMENT, AND PAIN, DISCOMFORT, URINARY SYMPTOMS AND STENT ENCRUSTATION COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TAMSULOSIN PARACETAMOL AND SOLIFENACIN FOR PAIN OR DISCOMFORT WAS NEEDED IN RELATION TO THE 777428 - INLAY URETERAL STENT WITH HYDROGLIDE GUIDEWIRE,4.7 FR.,28CM. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097216 ↗
• InjuryJun 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PHYSICIAN STATED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, INFECTION, HEMATURIA PRIOR TO THE DEVICE PLACEMENT, AND PAIN, DISCOMFORT, URINARY SYMPTOMS AND STENT ENCRUSTATION COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE AND TAMSULOSIN PARACETAMOL AND SOLIFENACIN FOR PAIN OR DISCOMFORT WAS NEEDED IN RELATION TO THE 777428 - INLAY URETERAL STENT WITH HYDROGLIDE GUIDEWIRE,4.7 FR.,28CM. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY SYMPTOMS.

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

  MAUDE report 17088279 ↗
• MalfunctionDec 23, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON UNPACKING, THE STENT WAS FOUND RUPTURED AT THE PROXIMAL END AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043086 ↗
• InjuryDec 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT URETERAL CALCULUS LITHOTRIPSY UNDER GENERAL ANESTHESIA, URETERAL STRICTURE AND DILATION, AND URETERAL STENT IMPLANTATION. ANTI-INFECTION AND OTHER SYMPTOMATIC TREATMENT WERE GIVEN POSTOPERATIVELY. THE URETERAL STENT WAS REVIEWED IN GOOD PLACE AND THE PATIENT WAS ARRANGED FOR DISCHARGE. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT DEVELOPED FREQUENT AND URGENT URINATION, ACCOMPANIED BY DYSURIA, LOW BACK PAIN, AND LOW-GRADE FEVER. PATIENT CAME TO THE HOSPITAL AGAIN FOR TREATMENT. AFTER GIVING SYMPTOMATIC TREATMENT, THE PATIENT FELT BETTER. IT WAS NECESSARY TO REMOVE THE URETERAL STENT IN ADVANCE. IT WAS UNKNOWN IF THE DEVICE CAUSED FREQUENT AND URGENT URINATION, ACCOMPANIED BY DYSURIA, LOW BACK PAIN, AND LOW-GRADE FEVER.

  Patient problems: Dysuria; Fever; Pain; Urinary Frequency / Polyuria

  MAUDE report 16003759 ↗
• MalfunctionNov 7, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT COME OUT AFTER BEING GENTLY PULLED AFTER BEING FILLED WITH 10ML OF WATER. THE CATHETER CAME OUT ON ITS OWN THE NEXT DAY, AND AN INSPECTION REVEALED THAT THE AIRBAG HAD BROKEN. ALSO STATED THAT THE NURSE REPLACED THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760221 ↗
• MalfunctionNov 3, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE URINARY TUBE WAS FOUND TO SLIP OFF THE NEXT MORNING, AND THE FOLEY CATHETER BALLOON WAS BROKEN, WHICH WAS INSERTED INTO THE PATIENT ON (B)(6) 2021. IT WAS ALSO STATED THAT THE BALLOON WAS INFLATED AND CHECKED BEFORE THE OPERATION, AND 15ML OF NORMAL SALINE WAS INJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746682 ↗
• MalfunctionNov 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT TUBE RUPTURED AT THE PIGTAIL COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737391 ↗
• MalfunctionNov 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE URETERAL STENT TUBE WAS UNTWISTED. THEREFORE, IT WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737390 ↗
• MalfunctionFeb 26, 2018Break

  IT WAS REPORTED THAT THE COIL WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7297653 ↗