Bard InLay Ureteral StentRecalls & reported problems across all models

We found 11 models of Bard InLay Ureteral Stent by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 198 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Apr 8, 2026 — classified as 61 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (76 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard InLay Ureteral Stent problems

Bard InLay Ureteral Stent models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® InLay® Ureteral Stent 778626

  STENT, URETERAL
  100 reports
• Bard® InLay® Ureteral Stent 778426

  STENT, URETERAL
  56 reports
• Bard® InLay® Ureteral Stent 778624

  STENT, URETERAL
  22 reports
• Bard® InLay® Ureteral Stent 778424

  STENT, URETERAL
  5 reports
• Bard® InLay® Ureteral Stent 778726

  STENT, URETERAL
  5 reports
• Bard® InLay® Ureteral Stent 778724

  STENT, URETERAL
  3 reports
• Bard® InLay® Ureteral Stent 778428

  STENT, URETERAL
  2 reports
• Bard® InLay® Ureteral Stent 778622

  STENT, URETERAL
  2 reports
• Bard® InLay® Ureteral Stent 778614

  STENT, URETERAL
  1 report
• Bard® InLay® Ureteral Stent 778722

  STENT, URETERAL
  1 report
• Bard® InLay® Ureteral Stent 778728

  STENT, URETERAL
  1 report

Recent Bard InLay Ureteral Stent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT BETWEEN (B)(6) 2026, A PROFESSOR AT A (B)(6) PERFORMED STONE REMOVAL SURGERIES, DURING WHICH DIFFICULTIES IN STENT PLACEMENT WERE ENCOUNTERED. DUE TO DEPARTMENTAL MANAGEMENT PROCESS ISSUES, DEFECTIVE PRODUCTS RETAINED FOR SEVERAL MONTHS, 3 AFFECTED UNITS WERE COLLECTIVELY REPORTED TO THE MANUFACTURER AT A UNIFIED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823524 ↗
• InjuryMar 18, 2026Calcified

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETERAL STENT PLACEMENT. ONE MONTH AFTER THE STENT WAS INSERTED, THE PATIENT EXPERIENCED LOWER BACK PAIN. UPON FOLLOW UP AT THE HOSPITAL, IT WAS FOUND THAT STONES HAD FORMED ON TWO SECTIONS OF THE STENT. THE DOCTOR REMOVED THE STENT WITH THE STONES AND REPLACED IT WITH A NEW ONE, AFTER WHICH THE PAIN SUBSIDED.

  Patient problems: Pain

  MAUDE report 24635024 ↗
• MalfunctionMar 18, 2026Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A URETERAL STENT PLACEMENT PROCEDURE, INSERTING STENT MODEL 778426, ONE WEEK AFTER PLACEMENT, THE STENT DISLODGED FROM THE PATIENT¿S BODY, AND THE PATIENT RETURNED TO THE HOSPITAL FOR REINSERTION OF A URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630919 ↗
• InjuryMar 17, 2026Calcified

  IT WAS REPORTED THAT, ON (B)(6) 2026, THE PATIENT REQUIRED REMOVAL OF A URETERAL STENT FOLLOWING URETEROSCOPIC LITHOTRIPSY AND STONE EXTRACTION FOR KIDNEY STONES. STENT 778426 HAD BEEN IN PLACE FOR 60 DAYS. DURING PREPARATION FOR THE PROCEDURE TO REMOVE THE URETERAL STENT, IT WAS DISCOVERED THAT THE STENT HAD FORMED A CRUST AS SHOWN IN THE PHOTO, MAKING IT IMPOSSIBLE TO REMOVE THE STENT SMOOTHLY. AFTER CLINICAL ASSESSMENT, IT WAS DECIDED TO USE SURGICAL INTERVENTION TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE STENT WAS SUCCESSFULLY REMOVED.

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

  MAUDE report 24621754 ↗
• MalfunctionJan 23, 2026Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT FLEXIBLE URETEROSCOPY LITHOTRIPSY AND STONE REMOVAL FOR RENAL CALCULI. DURING THE CATHETERIZATION PHASE OF THE PROCEDURE, THE SURGICAL PLAN CALLED FOR INSERTION OF URETERAL STENT 778626. AFTER UNPACKING THE STENT, A SMALL TEAR WAS DISCOVERED UPON INSERTION (VISIBLE IN THE PROVIDED PHOTOGRAPH). CLINICALLY, A NEW PACKAGE WAS OPENED. THE PRODUCT WAS FOUND TO BE FREE OF DEFECTS, AND SUBSEQUENT PROCEDURES WERE COMPLETED WITHOUT INCIDENT. THE SURGERY WAS SUCCESSFULLY CONCLUDED. THE PROCEDURE EXPERIENCED A DELAY BUT NO OTHER ADVERSE EFFECTS.

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

  MAUDE report 24172972 ↗
• InjuryJan 23, 2026Calcified

  IT WAS REPORTED THAT, ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPIC LITHOTRIPSY AND STONE REMOVAL FOR KIDNEY STONES. A STENT HAD BEEN IN PLACE FOR 20 DAYS AND WAS SCHEDULED FOR REMOVAL DURING SURGERY. DURING PREPARATION TO EXTRACT THE URETERAL STENT, ENCRUSTATION WAS OBSERVED ON THE STENT, PREVENTING ITS SMOOTH REMOVAL. FOLLOWING CLINICAL ASSESSMENT, SURGICAL INTERVENTION WAS CHOSEN TO EXTRACT THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE STENT WAS REMOVED WITHOUT INCIDENT.

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

  MAUDE report 24172899 ↗
• InjuryJan 23, 2026Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPIC LITHOTRIPSY AND STONE REMOVAL FOR KIDNEY STONES AND REQUIRED REMOVAL OF THE STENT. STENT 778426 HAD BEEN IN PLACE FOR 10 DAYS. DURING THE PROCEDURE TO REMOVE THE URETERAL STENT, IT WAS DISCOVERED THAT THE STENT HAD ENCRUSTATIONS (SEE PHOTOS), PREVENTING ITS SMOOTH REMOVAL. AFTER CLINICAL ASSESSMENT, SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE STENT WAS SUCCESSFULLY REMOVED.

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

  MAUDE report 24172255 ↗
• InjuryJan 23, 2026Calcified

  IT WAS REPORTED THAT ON (b)(6) 2025, THE PATIENT UNDERWENT TRANSURETHRAL LEFT URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY AND STONE REMOVAL PLUS URETERAL STENT PLACEMENT IN THE DEPARTMENT OF SURGERY AT OUR HOSPITAL. DURING THE PROCEDURE, A URETERAL STENT WAS PLACED: INLAY URETERAL STENTS 4.7FR X 26CM, CODE 1500000000010610. ON (b)(6) 2025, THE PATIENT UNDERWENT TRANSURETHRAL URETERAL STENT REMOVAL IN THE OUTPATIENT OPERATING ROOM. PREOPERATIVE REVIEW OF THE URINARY SYSTEM X-RAY SHOWED NO ABNORMALITIES. THE PATIENT WAS POSITIONED FOR STONE REMOVAL, CYSTOSCOPY SHOWED NORMAL BLADDER, AND AFTER ROUTINE DISINFECTION AND DRAPING, THE URETHRA WAS ENTERED AND THE BLADDER EXAMINED. THE LEFT URETERAL ORIFICE WAS OBSERVED TO CONTAIN THE URETERAL STENT, THE SURFACE OF WHICH WAS COVERED WITH STONES. USING FOREIGN BODY FORCEPS, THE LOWER END OF THE URETERAL STENT WAS PULLED TOWARD THE URETHRAL OPENING, ENCOUNTERING SIGNIFICANT RESISTANCE. IT WAS CONSIDERED THAT THE UPPER SEGMENT OF THE URETERAL STENT WAS ENCRUSTED WITH STONES. CYSTOSCOPY WAS REINTRODUCED TO THE BLADDER, AND WITH FOREIGN BODY FORCEPS, THE URETERAL STENT WAS SLOWLY PULLED FROM THE URETERAL ORIFICE UNTIL IT WAS COMPLETELY REMOVED THROU

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

  MAUDE report 24171810 ↗
• InjuryDec 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY AND URETERAL STENT PLACEMENT AT BEILIU CITY TRADITIONAL CHINESE MEDICINE HOSPITAL ON (B)(6) 2025 AND WAS SUBSEQUENTLY DISCHARGED. HOWEVER, ON (B)(6) 2025, THE PATIENT EXPERIENCED MILD DISTENDING PAIN IN THE RIGHT FLANK ACCOMPANIED BY DYSURIA AND HEMATURIA. THE PATIENT RETURNED TO THE HOSPITAL FOR FOLLOW-UP AND RECEIVED SYMPTOMATIC TREATMENT INCLUDING ANTI-INFLAMMATORY AND ANALGESIC THERAPY. THE PATIENT HAS BEEN EXPOSED TO HARMFUL SUBSTANCES, BLOOD OR BODY FLUIDS AND HOSPITALIZATION. SOLUTION: ADMINISTER SYMPTOMATIC TREATMENT INCLUDING ANTI-INFLAMMATORY AND ANALGESIC MEDICATIONS. MONITOR THE PATIENT'S CONDITION. REPLACE THE URETERAL STENT IF NECESSARY.

  Patient problems: Dysuria; Hematuria; Pain

  MAUDE report 23796756 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT TRANSURETHRAL URETEROSCOPY WITH HOLMIUM LASER LITHOTRIPSY AND URETERAL STENT PLACEMENT AT BEILIU CITY TRADITIONAL CHINESE MEDICINE HOSPITAL ON (B)(6) 2025 AND WAS SUBSEQUENTLY DISCHARGED. HOWEVER, ON (B)(6) 2025, THE PATIENT EXPERIENCED MILD DISTENDING PAIN IN THE RIGHT FLANK ACCOMPANIED BY DYSURIA AND HEMATURIA. THE PATIENT RETURNED TO THE HOSPITAL FOR FOLLOW-UP, WHERE SYMPTOMATIC TREATMENT INCLUDING ANTI-INFLAMMATORY AND ANALGESIC MEASURES WAS ADMINISTERED.

  Patient problems: Dysuria; Hematuria; Pain; Skin Inflammation/ Irritation; Urinary Tract Infection

  MAUDE report 23779616 ↗
• MalfunctionDec 5, 2025Accessory Incompatible; Improper Chemical Reaction; Accessory Incompatible; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARTIAL LEFT NEPHRECTOMY. TO PREVENT POSTOPERATIVE URINARY LEAKAGE, A DOUBLE-J STENT WAS PLACED IN THE URETER FOR INTERNAL DRAINAGE TO REDUCE RENAL PELVIC PRESSURE. A LEFT-SIDED DOUBLE-J STENT WAS INSERTED. AN F6 DOUBLE-J STENT WAS ATTEMPTED BUT ENCOUNTERED SIGNIFICANT DIFFICULTY DURING PLACEMENT OVER THE ZEBRA GUIDEWIRE. CONSIDERED FRICTION BETWEEN THE STENT LUMEN AND GUIDEWIRE, INITIALLY ATTRIBUTED TO INSUFFICIENT LUBRICATION. DESPITE ADEQUATE LUBRICATION, PLACEMENT REMAINED TIGHT, RAISING CONCERN FOR URETERAL STRICTURE. AN F5 URETERAL CATHETER WAS SUCCESSFULLY ADVANCED APPROXIMATELY 25 CM INTO THE URETER. SUBSEQUENTLY, AN F5 DOUBLE-J STENT WAS SELECTED AND SUCCESSFULLY PLACED OVER THE ZEBRA GUIDEWIRE TO THE TARGET LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735154 ↗
• InjuryNov 11, 2025Calcified; Calcified

  IT WAS REPORTED THAT WHEN THE PATIENT¿S URETERAL STENT WAS BEING REMOVED, THE STENT WAS SEVERELY CALCIFIED. DESPITE USING A HOLMIUM LASER, THE STONES COULD NOT BE COMPLETELY FRAGMENTED, AND THE STENT COULD NOT BE REMOVED. SURGICAL INTERVENTION NEEDED AS FURTHER TREATMENT WILL REQUIRE TRANSFER TO ANOTHER HOSPITAL FOR STENT REMOVAL.

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

  MAUDE report 23522778 ↗
• InjuryNov 7, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETERAL STONE SURGERY AND URETERAL STENT PLACEMENT IN HOSPITAL'S OPERATING ROOM ON (B)(6) 2025, FOR URETERAL STONES. THE PROCEDURE WAS PERFORMED CORRECTLY. ON (B)(6) 2025, THE PATIENT RETURNED TO THE HOSPITAL AS SCHEDULED FOR STENT REMOVAL. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE STENT WAS COVERED WITH NUMEROUS STONES FORMING A STONE SHEATH. FURTHER INVESTIGATION REVEALED THAT MULTIPLE CASES OF STENTS COVERED WITH STONES HAD OCCURRED USING THIS BATCH OF SUPPLIES, SUGGESTING A SERIOUS QUALITY ISSUE WITH THE URETERAL STENT. AFTER STENT REMOVAL, THE PATIENT EXPERIENCED ABDOMINAL PAIN IN THE (B)(6) 2025, AND PRESENTED TO THE EMERGENCY DEPARTMENT. A CT SCAN REVEALED MULTIPLE STONES IN THE RIGHT URETER, LIKELY DUE TO SHEATH DISLODGEMENT, REQUIRING A SECOND HOSPITALIZATION FOR STONE REMOVAL SURGERY.

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

  MAUDE report 23497746 ↗
• InjuryOct 27, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE HOSPITAL RECEIVED THE XINRUI STENTS IN JULY THIS YEAR, WITH 50 UNITS OF BATCH NUMBER NGKN2932 DELIVERED. AMONG THESE, 5 STENTS FROM BATCH NGKN2932 CAUSED SEVERE LONG-TERM STONE FORMATION IN 5 PATIENTS. THE STENTS REMAINED IN PLACE FOR ONE MONTH. SURGEONS INVOLVED: (4 PHYSICIANS TOTAL). THIS HIGH INCIDENCE OF CALCIFICATION HAS LED THE DEPARTMENT TO SERIOUSLY QUESTION THE QUALITY OF BARD STENTS, RESULTING IN THEIR REFUSAL TO INCLUDE BARD STENTS IN THE CENTRALIZED PROCUREMENT BIDDING. THE CALCIFIED STENTS HAVE BEEN DISCARDED, WITH ONLY PARTIAL IMAGES RETAINED FOR SUBMISSION TO THE COMPANY. INDIVIDUAL PATIENTS REQUIRED SECONDARY SURGERY FOR LITHOTRIPSY AND STONE REMOVAL. AND THE PATIENT WAS HOSPITALIZED. PATIENT WAS EXPOSED TO HAZARDOUS SUBSTANCES, BLOOD, OR BODILY FLUIDS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Exposure to Body Fluids

  MAUDE report 23393603 ↗
• MalfunctionOct 22, 2025Calcified; Calcified

  IT WAS REPORTED THAT AFTER THE NEW RUI STENTS WERE LEFT IN THREE PATIENTS FOR THREE WEEKS, IT WAS FOUND DURING REMOVAL THAT ALL THREE PATIENTS HAD SEVERE STONE FORMATION ON THE STENTS. THE CLIENT EXPRESSED CONCERN ABOUT THE TENDENCY OF THE NEW RUI STENTS TO DEVELOP STONES AND HOPES THAT THE COMPANY'S PRODUCT PROCESS CAN BE IMPROVED IN THE FUTURE TO REDUCE THE OCCURRENCE OF STONE FORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358010 ↗

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