Bard® InLay® Ureteral Stent 778426Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00801741014765), received between Jul 3, 2018 and Apr 8, 2026 — classified as 26 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Calcified” (25 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 25 most recent of 56 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 3, 2025Calcified; Calcified

  IT WAS REPORTED THAT AFTER STONE SURGERY, A URETERAL STENT WAS PLACED. LESS THAN A MONTH AFTER THE STENT WAS PLACED, A STONE DEVELOPED, WHICH WAS NOW QUITE SEVERE AND REQUIRED HOLMIUM LASER LITHOTRIPSY.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22954609 ↗
• InjuryAug 21, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY AND LITHOTRIPSY FOR KIDNEY STONES AND REQUIRED REMOVAL OF A STENT THAT HAD BEEN IN PLACE FOR 25 DAYS. DURING PREPARATION FOR THE PROCEDURE, IT WAS DISCOVERED THAT THE STENT HAD BECOME ENCRUSTED AND COULD NOT BE REMOVED. AFTER CLINICAL EVALUATION, SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE STENT WAS REMOVED.

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

  MAUDE report 22864976 ↗
• MalfunctionAug 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT URETEROSCOPY FOR KIDNEY STONES AND REQUIRED REMOVAL OF A STENT. THE URETERAL STENT 778426 HAD BEEN IN PLACE FOR 30 DAYS. DURING PREPARATION FOR REMOVAL, IT WAS FOUND THAT THE STENT HAD CRUSTED OVER, MAKING IT IMPOSSIBLE TO REMOVE SMOOTHLY. AFTER CLINICAL ASSESSMENT, SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE STENT REMOVED. IT INCREASES SURGICAL PROCEDURE TIME AND COSTS.

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

  MAUDE report 22827890 ↗
• InjuryAug 18, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT UNDERWENT URETEROSCOPY FOR KIDNEY STONES AND REQUIRED REMOVAL OF A STENT. THE URETERAL STENT 778426 HAD BEEN IN PLACE FOR 30 DAYS. DURING PREPARATION FOR REMOVAL, IT WAS FOUND THAT THE STENT HAD CRUSTED OVER, MAKING IT IMPOSSIBLE TO REMOVE SMOOTHLY. AFTER CLINICAL ASSESSMENT, SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE STENT REMOVED. IT INCREASES SURGICAL PROCEDURE TIME AND COSTS.

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

  MAUDE report 22827876 ↗
• MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, ON (B)(6) 2025, UPON INSPECTION OF THE OUTER PACKAGING IT WAS FOUND TO BE INTACT. WHEN OPENED THE PRODUCT PACKAGING, REMOVED THE URETERAL STENT WITH MATERIAL NUMBER 778426, CUT THE SUTURES WITH SCISSORS, AND PREPARED TO PLACE IT. UPON STRAIGHTENING IT, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO THREE PIECES. THE SURGERY COULD NOT BE COMPLETED, SO THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783194 ↗
• MalfunctionJun 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6)2025, THE PATIENT UNDERWENT URETEROSCOPY FOR KIDNEY STONES. DURING THE SURGERY, WHEN THE PROCEDURE REACHED THE CATHETER PLACEMENT STAGE, A URETERAL STENT WAS INSERTED. AFTER UNPACKING THE STENT, A SMALL NOTCH WAS FOUND AT THE END OF THE STENT RESEMBLING A PIG'S TAIL FOR WHICH ACTUAL SAMPLE AND PHOTOS ARE AVAILABLE. AFTER CLINICAL ASSESSMENT, A NEW PACKAGE WAS CHOSEN, AND THE PRODUCT HAD NO ISSUES, ALLOWING THE SUBSEQUENT PROCEDURES TO BE COMPLETED SMOOTHLY AND THE SURGERY TO BE SUCCESSFULLY FINISHED. THERE WAS A DELAY IN THE SURGERY, BUT NO OTHER IMPACTS.

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

  MAUDE report 22236627 ↗
• InjuryJun 12, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT NEEDED TO REMOVE THE STENT AFTER URETEROSCOPIC LITHOTRIPSY FOR KIDNEY STONES. THE STENT HAD BEEN IN PLACE FOR 20 DAYS. DURING THE OPERATION TO REMOVE THE URETERAL STENT, IT WAS FOUND THAT THE URETERAL STENT WAS SEVERELY ENCRUSTED AND COULD NOT BE REMOVED SMOOTHLY. AFTER CLINICAL JUDGMENT, SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT. THE OPERATION WAS SUCCESSFULLY COMPLETED, AND THE STENT WAS REMOVED SMOOTHLY. SURGICAL INTERVENTION IS REQUIRED TO REMOVE THE URETERAL STENT, INCREASING THE TIME AND COST OF SURGICAL MANEUVERS.

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

  MAUDE report 22194604 ↗
• MalfunctionJun 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE STENT AFTER OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176163 ↗
• MalfunctionMay 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BEFORE USE, THE CUSTOMER OPENED THE PACKAGE OF THE PRODUCT AND FOUND THAT THE STENT OF MODEL 778626 WAS BROKEN AND WAS NOT CONTINUED TO BE USED. AFTER REPLACING THE PRODUCT WITH A NEW ONE, THE SURGERY WAS CONTINUED AND THERE WAS NO IMPACT ON THE PATIENT DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115191 ↗
• MalfunctionJan 30, 2025Calcified; Calcified

  IT WAS REPORTED THAT THERE WERE TWO PATIENTS. ONE PATIENT HAD STENT 778426 PLACED FOR 30 DAYS. DURING THE PROCESS OF EXTUBATION, THE STENT HAD SERIOUS STONES, WHICH TOOK A LONG TIME TO EXTUBATE. ANOTHER PATIENT HAD STENT 778426 PLACED FOR 35 DAYS. DURING THE PROCESS OF EXTUBATION, THE STENT HAD SERIOUS STONES, WHICH TOOK A LONG TIME TO EXTUBATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273773 ↗
• MalfunctionJan 30, 2025Calcified; Calcified

  IT WAS REPORTED THAT THERE WERE TWO PATIENTS. ONE PATIENT HAD STENT 778426 PLACED FOR 30 DAYS. DURING THE PROCESS OF EXTUBATION, THE STENT HAD SERIOUS STONES, WHICH TOOK A LONG TIME TO EXTUBATE. ANOTHER PATIENT HAD STENT 778426 PLACED FOR 35 DAYS. DURING THE PROCESS OF EXTUBATION, THE STENT HAD SERIOUS STONES, WHICH TOOK A LONG TIME TO EXTUBATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272907 ↗
• MalfunctionJan 3, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE 778426 URETERAL STENT WAS PLACED 40 DAYS LATER. DURING THE PROCESS OF EXTUBATION, THE STENT HAD SERIOUS STONES, WHICH TOOK A LONG TIME TO EXTUBATE. THE PATIENT HAD HEPATITIS B AND HAD A STENT PLACED DURING SOFT ENDOSCOPY STONE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066318 ↗
• MalfunctionDec 27, 2024Calcified; Calcified

  IT WAS REPORTED THAT 45 DAYS AFTER THE STENT 778426 WAS PLACED, DURING THE PATIENT'S EXTUBATION, THE STENT HAD A SEVERE CASE OF LONG STONES, RESULTING IN A PROLONGED EXTUBATION.

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

  MAUDE report 21026178 ↗
• MalfunctionDec 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE KIDNEY STONES WERE CRUSHED AND BEFORE THE INSERTION PROCESS OF THE URETERAL STENT, THE PACKAGING BOX WAS OPENED AND FOUND TO BE UNUSUAL. THE INNERMOST PACKAGING OF THE STENT WAS OPENED, AND THE SILK THREAD WAS CUT AND FOUND TO BE BROKEN WHEN IT WAS TAKEN OUT, SO THE CUSTOMER TERMINATED THE USE OF THIS ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011193 ↗
• InjuryDec 6, 2024Calcified; Calcified

  IT WAS REPORTED THAT THE AFTER PLACEMENT OF THE SUNRAY STENT IN A PREGNANT PATIENT, THE URETERAL STENT HAD A SEVERE CASE OF STONE FORMATION, AND EVENTUALLY, DURING EXTUBATION, IT COULD NOT BE REMOVED, AND THE CLIENT REMOVED IT WITH HOLMIUM LASER LITHOTRIPSY.

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

  MAUDE report 20865012 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT URETERAL DOUBLE J TUBE PLACEMENT IN OUR HOSPITAL DUE TO LEFT URETERAL CALCULI. THE PATIENT RECOVERED WELL AFTER THE OPERATION. ON (B)(6) 2024, THE DOUBLE J TUBE WAS REPLACED IN OUR HOSPITAL DUE TO URINARY TRACT FUNGAL INFECTION. ON (B)(6), URINE CULTURE WAS PERFORMED FOR 3 CONSECUTIVE DAYS, AND THE RESULTS SHOWED NO BACTERIAL INFECTION, INDICATING THAT THE INFECTION HAD BEEN CONTROLLED, SO THE URETERAL STENT WAS REMOVED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Fungal Infection; Urinary Tract Infection

  MAUDE report 20864080 ↗
• InjuryNov 27, 2024Calcified; Calcified

  IT WAS REPORTED THAT CUSTOMERS USING THE 778 SERIES STENTS REPORTED THAT IN MANY CASES THE STENTS WERE INDWELLING FOR ABOUT A MONTH. DURING THE REMOVAL OF THE TUBE, IT WAS FOUND THAT THE STENTS WERE COVERED WITH CRUSTS AND ADHERED TO THE URETERAL WALL, MAKING REMOVAL OF THE TUBE DIFFICULT AND REQUIRED SECOND ANESTHESIA TO BE SURGICALLY REMOVED. THERE WAS PROLONGED SURGERY WHICH REQUIRED USE OF NEW STENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6)2024, CUSTOMER CONFIRMED THAT THE PATIENT'S STENT WAS SUCCESSFULLY REMOVED AFTER RE-ANESTHETIC SURGERY.

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

  MAUDE report 20790977 ↗
• InjuryOct 14, 2024Calcified; Calcified

  IT WAS REPORTED THAT AFTER THE FLEXIBLE URETEROSCOPY, URETERAL STENT WAS PLACED IN THE PATIENT, AND HEMATURIA OCCURRED FOR A WEEK, AND A LARGE NUMBER OF STONES ON THE SURFACE OF THE STENT WERE FOUND ON REEXAMINATION. PATIENT WAS EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS.

  Patient problems: Exposure to Body Fluids; Hematuria

  MAUDE report 20438944 ↗