Bard® InLay® Ureteral Stent 778626Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00801741014833), received between Jan 10, 2018 and Mar 18, 2026 — classified as 22 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (45 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 100 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENED THE URETERAL STENT PACKAGING, THE FOUND THAT THE STENT WAS BROKEN. THEY DID NOT CONTINUE TO USE IT. THEY REPLACED IT WITH A NEW PRODUCT AND CONTINUED THE OPERATION. THERE WAS NO IMPACT ON THE PATIENT DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939195 ↗
• InjuryAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO ANASTOMOTIC STENOSIS AND URINARY TRACT INFECTION. AFTER ADMISSION, THE PATIENT UNDERWENT A TRANS-STOMATIC URETERAL STENT REPLACEMENT IN THE OPERATING ROOM ON (B)(6) 2025. ON THE FIRST DAY POST-SURGERY, THE RESERVED URETERAL STENT WAS OBSERVED TO HAD EXTRUDED OUTSIDE THE BODY, NECESSITATING A REPEAT REPLACEMENT OF THE URETERAL STENT FOR DRAINAGE. IF NOT ADDRESSED PROMPTLY, THIS WOULD HINDER DRAINAGE FOR THE PATIENT, LEADING TO A SECOND SURGERY, FURTHER INJURY TO THE PATIENT, AND AN INCREASED TREATMENT DURATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 22894429 ↗
• MalfunctionAug 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER OPENING THE PRODUCT PACKAGING, THE CUSTOMER FOUND THAT THE 778626 STENT WAS FRACTURED AND DID NOT CONTINUE TO USE IT. AFTER REPLACING IT WITH A NEW PRODUCT, THE SURGERY CONTINUED AND THERE WAS NO IMPACT ON THE PATIENT DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840488 ↗
• MalfunctionJun 27, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, AFTER THE STENT WAS OPENED, THE HEAD END WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346220 ↗
• MalfunctionMay 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE AFTER OPENING THE PRODUCT PACKAGING, THE CUSTOMER DISCOVERED THAT THE 778626 MODEL URETERAL STENT WAS BROKEN. THE STENT WAS NOT USED ANY FURTHER AND WAS REPLACED WITH A NEW ONE DURING THE OPERATION. THERE WAS NO IMPACT ON THE PATIENT DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078483 ↗
• MalfunctionMay 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT TRANSURETHRAL URETERAL LASER LITHOTRIPSY UNDER GENERAL ANESTHESIA IN THE CENTRAL OPERATING ROOM. AFTER THE SURGEON REMOVED THE STONES, THEY PREPARED TO PLACE THE URETERAL STENT. THE CIRCULATING NURSE BROUGHT THE URETERAL STENT TO THE OPERATING TABLE. THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE MIDDLE SECTION OF THE URETERAL STENT WAS BROKEN AND COULD NOT BE USED. THE URETERAL STENT WAS REPLACED AND THE OPERATION CONTINUED. MAY PROLONG SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069417 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT BILATERAL TRANSURETHRAL FLEXIBLE ENDOSCOPIC LASER LITHOTRIPSY AND STENT PLACEMENT. AFTER THE OPERATION, WHEN PREPARING TO PLACE A URETERAL STENT, THE ASSISTANT REMOVED THE STERILE OUTER PACKAGING AND FOUND THAT ONE END OF THE STENT WAS COMPLETELY BROKEN. AFTER THE DISCOVERY, THE CIRCULATING NURSE WAS INFORMED IN TIME, AND IT DID NOT AFFECT THE PATIENT. AFTER THE CIRCULATING NURSE DISCOVERED IT, THEY IMMEDIATELY REMOVED THE STENT AND REPLACED IT WITH A NEW ONE. THE OPERATION CONTINUED AND THE PATIENT RETURNED TO THE WARD SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036427 ↗
• MalfunctionMay 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE UPON OPENING THE PACKAGE, THE URETERAL STENT BRACKET WAS FOUND TO BE BROKEN, AND THE FILAMENT HAD NOT BEEN REMOVED. THE SOLUTION WAS TO REPLACE THE BRACKET WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004057 ↗
• MalfunctionApr 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UNPACKED AND OPENED THE STENT AND FOUND THE HEAD END OF THE STENT WAS BROKEN AND UNUSABLE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT THEY REPLACED THE BRACKET WITH A NEW ONE. THE BROKEN STENT WAS NOT USED, AND A NEW STENT HAD BEEN REPLACED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892828 ↗
• MalfunctionApr 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UNPACKED AND OPENED THE STENT AND FOUND THE HEAD END OF THE STENT WAS BROKEN AND UNUSABLE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 22APR2025, STATED THAT THEY REPLACED THE STENT WITH A NEW ONE. THE BROKEN STENT WAS NOT USED, AND A NEW STENT HAD BEEN REPLACED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890303 ↗
• MalfunctionApr 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETEROSCOPIC STENT PLACEMENT IN THE OPERATING ROOM ON (B)(6) 2025, DUE TO URETERAL STONES. THE URETERAL STENT BROKE DURING THE OPERATION. AFTER THE DOCTOR LEARNED ABOUT IT, THEY TOOK MEASURES TO REPLACE THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882910 ↗
• MalfunctionMar 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER OPENED THE PACKAGE OF THE PRODUCT AND FOUND THAT THE STENT WAS BROKEN AND DID NOT CONTINUE TO BE USED, AND THE OPERATION CONTINUED AFTER REPLACED WITH THE NEW PRODUCT. AT PRESENT, THE GUIDEWIRE ON THE HOSPITAL STENT WAS REMOVED, AND THERE WAS NO CLINICAL FEEDBACK ON WHY THE GUIDEWIRE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503967 ↗
• MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS USED IN URETERAL STONE SURGERY, WHEN THE PACKAGE WAS UNPACKED, IT WAS FOUND TO BE BROKEN, AND THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PACKAGE WITH A URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285252 ↗
• MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ON (B)(6) 2025, THE PATIENT HAD DRAINAGE OF HYDRONEPHROSIS. BEFORE THE URETERAL STENT WAS PLACED, THE URETERAL STENT BROKE ACCIDENTALLY WHEN THE GUIDE SLEEVE AND THREAD WERE REMOVED AFTER THE URETERAL STENT WAS MOISTENED. A NEW URETERAL STENT WAS THEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282475 ↗
• MalfunctionJan 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT NEEDED A URETERAL STENT AFTER URETEROSCOPIC LITHOTRIPSY TO ELIMINATE OBSTRUCTION CAUSED BY VARIOUS BENIGN, MALIGNANT AND POST-TRAUMATIC DISEASES IN THE URETER. THE PATIENT SELECTED PRODUCT (B)(6). WHEN THE DOCTOR WAS ABOUT TO INSERT THE URETERAL STENT DURING THE OPERATION, THE STENT ITSELF WAS BLOCKED BY THE LABEL ON THE PACKAGE AND COULD NOT BE FULLY SEEN. AFTER THE CIRCULATING NURSE OPENED THE PACKAGE, NURSE FOUND THAT THE ROD OF THE STENT WAS BROKEN, AND THE SILK THREAD WAS ENTANGLED WITH THE STENT. THEREFORE, THE PRODUCT COULD NOT BE USED, WHICH PROLONGED THE OPERATION TIME. IN ORDER TO ENSURE THE COMPLETION OF THE OPERATION, THE SURGEON REQUESTED TO REOPEN THE NEW PRODUCT AND THEN PLACED IT. THE SUBSEQUENT PATIENT'S OPERATION WENT SMOOTHLY.

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

  MAUDE report 21265099 ↗
• InjuryDec 30, 2024Calcified; Calcified

  IT WAS REPORTED THAT IN (B)(6) 2024, THE PATIENT WAS CATHETERIZED FOR URETERAL STENOSIS WITH A SUNRAY STENT 778626. 6 MONTHS AFTER PLACEMENT, STONES GREW ON THE SURFACE OF THE STENT, MAKING IT IMPOSSIBLE FOR THE PATIENT TO BE EXTUBATED AS USUAL, AND THE CLINICAL OPTION WAS TO REMOVE THE STENT BY SURGICAL INTERVENTION. AFTER REMOVAL OF THE STENT, THE PATIENT'S CONDITION WAS NORMAL. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE, WHICH INCREASED THE COST OF THE PROCEDURE, AND AFTER REMOVAL OF THE STENT, THE PATIENT'S CONDITION WAS NORMAL; THE CLINIC INCREASED THE VOLUME OF PROCEDURES AND CLINICAL DIAGNOSTIC WORK.

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

  MAUDE report 21034573 ↗
• MalfunctionDec 29, 2024Calcified; Calcified

  IT WAS REPORTED THAT THE PREGNANT WOMAN WITH URETERAL COMPRESSION WAS ADMITTED TO THE HOSPITAL AND A URETERAL STENT WAS PLACED, WHICH WAS LEFT IN THE PATIENT FOR ABOUT THREE MONTHS TO GROW STONES, WHICH ARE NOW MORE SEVERE AND MAY REQUIRE HOLMIUM LASER LITHOTRIPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032739 ↗