Bard® InLay Optima® Ureteral Stent 788426Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00801741015687), received between Jul 19, 2017 and Jun 26, 2026 — classified as 32 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (44 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 6, 2025Class IIOpen, Classified

   Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

   Z-0906-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJun 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DOCTOR OPENED THE STENT STERILE PACKAGING AND DISCOVERED SMALL, BLACK, HAIR LIKE FOREIGN MATTER INSIDE, CONFIRMING THAT THE PRODUCT WAS CONTAMINATED AND UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643281 ↗
• InjuryApr 22, 2026Calcified

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE SURGERY FOR URETERAL STONES, AND URETERAL STRICTURE WAS OBSERVED DURING THE OPERATION, SO A URETERAL STENT WAS PLACED. ON (B)(6) 2025, THE PATIENT RETURNED FOR A FOLLOW UP AND HAD A 4.7FR URETERAL STENT BARD REPLACED. THE THEORETICAL LIFESPAN OF THIS TYPE OF URETERAL STENT IS MORE THAN ONE YEAR, AND THE PATIENT WAS ADVISED TO RETURN FOR A FOLLOW UP AFTER SIX MONTHS TO REPLACE OR REMOVE THE URETERAL STENT. ON (B)(6) 2026, THE PATIENT RETURNED TO THE HOSPITAL FOR PLANNED REMOVAL OF THE URETERAL STENT AFTER A SIX-MONTH INTERVAL, BUT THE STENT WAS FOUND TO BE ENTRAPPED AND COULD NOT BE REMOVED. AFTER HOSPITALIZATION, SURGICAL TREATMENT WAS PERFORMED UNDER ANESTHESIA. DURING THE SURGERY, STONES WERE OBSERVED ON THE SURFACE OF THE LEFT URETERAL STENT, AND A THIN SHELL STONE HAD ADHERED TO THE UPPER SEGMENT OF THE LEFT URETERAL STENT. THE STONES WERE CRUSHED WITH LITHOTRIPSY FORCEPS AND THE URETERAL STENT ALONG WITH THE STONES WAS GRADUALLY REMOVED, AND A URETERAL STENT WAS REINSERTED. THE THEORETICAL LIFESPAN OF THIS TYPE OF URETERAL STENT WAS MORE THAN ONE YEAR, BUT IN THIS PATIENT, STONE ADHESION OCCURRED ON THE STENT SURFACE WI

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24960243 ↗
• MalfunctionApr 21, 2026Calcified

  IT WAS REPORTED THAT THE PATIENT HAD A URETERAL STENT THAT WAS REPLACED PERIODICALLY AFTER RADIATION THERAPY FOR A GYNECOLOGIC TUMOR. THE STENT WAS LAST INSERTED ON (B)(6) 2025, WITH A 4.7FR URETERAL STENT. ON (B)(6) 2026 WHEN THE URETERAL STENT WAS REPLACED, STONES WERE FOUND ADHERING TO THE SURFACE OF THE URETERAL STENT. THE THEORETICAL LIFE SPAN OF THIS TYPE OF URETERAL STENT IS MORE THAN 1 YEAR, BUT WHEN THE PATIENT HAD THE URETERAL STENT REPLACED IN OCTOBER, THERE WERE STONES ADHERING TO THE SURFACE OF THE URETERAL STENT, WHICH MAY LEAD TO DIFFICULTIES IN REMOVING THE STENT FROM THE URETER, AND OTHER ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940106 ↗
• MalfunctionFeb 12, 2026Difficult to Insert

  IT WAS REPORTED THAT, GUIDEWIRE ENTRY WAS FAILED AT DISTAL TIP OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328753 ↗
• MalfunctionFeb 9, 2026Calcified

  IT WAS REPORTED THAT AFTER URETEROSCOPIC LASER LITHOTRIPSY AND STONE REMOVAL, A STONE WAS FOUND ATTACHED TO THE URETERAL STENT WALL DURING A STENT CHANGE PROCEDURE A MONTH LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294735 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCESS OF CATHETERIZATION WITH A CYSTOSCOPE, THE URETERAL STENT BENT AND COULD NOT BE INSERTED SMOOTHLY, AND THE SUTURE THREAD HAS BEEN REMOVED. REPLACE WITH A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172973 ↗
• MalfunctionDec 30, 2025Calcified; Calcified

  IT WAS REPORTED THAT AFTER STENT PLACEMENT FOLLOWING KIDNEY STONE SURGERY, THE PATIENT DEVELOPED VERY SEVERE KIDNEY STONES. SOLUTION: REPLACE THE STENT WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930104 ↗
• MalfunctionDec 11, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE URETERAL STENT PLACEMENT PROCESS, THERE WAS A STUCK WITH THE POCO ZEBRA GUIDEWIRE, WHICH COULD NOT BE INSERTED SMOOTHLY, AND THE SILK THREAD WAS NOT REMOVED. REPLACE THE GUIDEWIRE WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780080 ↗
• InjuryNov 26, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT PATIENT REQUIRED A URETERAL STENT AFTER URETEROSCOPIC LITHOTRIPSY TO ELIMINATE OBSTRUCTIONS CAUSED BY VARIOUS BENIGN, MALIGNANT, AND POST TRAUMATIC CONDITIONS IN THE URETER. THE PATIENT USED URETERAL STENT. TWO WEEKS AFTER THE SURGERY, FLUOROSCOPY REVEALED THAT THE URETERAL STENT WAS PLACED IN THE UPPER LEFT URETER. DURING THE PROCEDURE, WHEN THE DOCTOR WAS PREPARING TO REMOVE THE STENT, IT BROKE OFF AFTER BEING PULLED OUT OF THE BODY. THERE WAS NO RESISTANCE WHEN REMOVING THE STENT, INDICATING THAT IT HAD BROKEN OFF INSIDE THE PATIENT. THE TAIL END OF THE STENT WAS BROKEN OFF AND REMOVED USING SURGICAL FORCEPS. THE SUBSEQUENT SURGERY WAS SUCCESSFUL. MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 23658271 ↗
• InjuryNov 11, 2025Calcified; Calcified

  IT WAS REPORTED THAT, ON (B)(6) 2025, THE PATIENT UNDERWENT A CYSTOSCOPIC STENT REMOVAL PROCEDURE TO EXTRACT THE URETERAL STENT. A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE WAS PERFORMED TO PLACE AN URETERAL STENT, WHICH WAS SCHEDULED FOR REMOVAL AFTER 60 DAYS. UPON EXAMINATION, THE STENT WAS FOUND TO BE EXTENSIVELY ENCRUSTED WITH CALCULI, MAKING EXTRACTION DIFFICULT. FOLLOWING CLINICAL ASSESSMENT, SURGICAL INTERVENTION WAS SELECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH THE STENT REMOVED WITHOUT COMPLICATIONS.

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

  MAUDE report 23523451 ↗
• MalfunctionSep 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE USING THE URETERAL STENT, IT BROKE WHEN IT WAS DELIVERED TO THE TABLE. THE HOSPITAL CONTACTED THE COMPANY, AND THE COMPANY FEEDBACK DETAILED INFORMATION TO THEIR COMPANY ON 10JUNE2025, HOPING TO BE GIVEN A REPLACEMENT. PER INVESTIGATION NOTIFICATION RECEIVED VIA TASK ON 26SEP2025, STATED THAT, ADDITIONAL COMPLAINT NEEDED AS STENT BREAKAGE FOUND IN RETURNED SAMPLE. RETURNED SAMPLE BATCH NUMBER DID NOT MATCH REPORTED COMPLAINT BATCH NUMBER. PCN 788426 AND BATCH NUMBER NGJN0534 FOR NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167115 ↗
• MalfunctionSep 10, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE URETEROSCOPY LITHOTRIPSY, IT WAS FOUND THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE STENT WHILE INSTALLING IT, RESULTING IN A STENT BLOCKAGE. AFTER REPLACING THE STENT WITH A J-STENT, AND THE BLOCKAGE ISSUE WAS STILL NOT RESOLVED, AND ONLY AFTER REPLACING THE STENT AGAIN THE PROBLEM WAS RESOLVED. DURING THIS PROCESS, THE COATING OF THE GUIDEWIRE CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015814 ↗
• MalfunctionAug 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING URETEROSCOPIC LITHOTRIPSY, UPON OPENING THE PACKAGING AND CUTTING THE SUTURE THREAD TO PREPARE FOR URETERAL STENT PLACEMENT, THE DISTAL END OF THE STENT WAS FOUND TO BE FRACTURED WHILE POSITIONING IT ONTO THE GUIDEWIRE. THE STENT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923913 ↗
• MalfunctionAug 28, 2025Dull, Blunt; Material Protrusion/Extrusion; Dull, Blunt; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING THE URETEROSCOPE LITHOTRIPSY, IT WAS FOUND THAT THE URETERAL STENT COULD NOT BE SMOOTHLY PLACED IN WHEN INSTALLING IT AND WAS PRONE TO STACKING. THE PROBLEM WAS RESOLVED AFTER REPLACING THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911783 ↗
• MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF THE URETERAL STENT WAS DAMAGED UPON OPENING AND COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728899 ↗
• MalfunctionJul 30, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE URETERAL STENT PLACEMENT PROCESS, THERE WAS A BLOCKAGE WITH THE GUIDE WIRE BOCCA SENSOR, MAKING IT IMPOSSIBLE TO PLACE IT SMOOTHLY, AND THE WIRE HAD NOT BEEN REMOVED AND WAS REPLACED WITH A NEW STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664502 ↗
• InjuryJul 11, 2025Calcified; Calcified

  IT WAS REPORTED THAT THE ON (B)(6) 2025, THE PATIENT NEEDED TO UNDERGO CYSTOSCOPIC LITHOTRIPSY TO REMOVE THE STENT. THE URETERAL STENT WAS PLACED DURING SOFT ENDOSCOPIC LITHOTRIPSY. AFTER 30 DAYS, THE STENT WAS PLANNED TO BE REMOVED. IT WAS FOUND THAT THE STENT WAS FULL OF STONES SEE THE STENT PHOTO, AND IT WAS DIFFICULT TO REMOVE. AFTER CLINICAL JUDGMENT, SURGICAL INTERVENTION WAS SELECTED. THE OPERATION WAS SUCCESSFULLY COMPLETED, AND THE STENT WAS SUCCESSFULLY REMOVED WITHOUT OTHER EFFECTS.

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

  MAUDE report 22480333 ↗
• MalfunctionJun 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETERAL STONE REMOVAL SURGERY USING A FLEXIBLE URETEROSCOPE DUE TO KIDNEY STONES. DURING THE SURGICAL PREPARATION, A URETERAL STENT WITH NUMBER 788426 WAS INSERTED, AND UPON INSPECTING THE OUTER PACKAGING, NO OBVIOUS ABNORMALITIES WERE FOUND. HOWEVER, AFTER UNWRAPPING THE PACKAGING TO TAKE IT OUT, IT WAS DISCOVERED THAT THE MIDDLE SECTION HAD A CRACK AND WAS BROKEN OFF. THE STENT WAS NOT USED, AND SAMPLES AND PHOTOGRAPHS WERE RETAINED. THE HOSPITAL REGULARLY USES THIS SERIES OF STENTS, AND AFTER UNWRAPPING OTHER PACKAGES, THE STENTS WERE FOUND TO BE NORMAL, ALLOWING THE SURGERY TO PROCEED SMOOTHLY WITHOUT ANY FURTHER IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358296 ↗
• MalfunctionJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE URETERAL STENT WAS OPENED, IT WAS FOUND TO BE CRACKED, AND THEN A REPLACEMENT OF THE SAME SPECIFICATION PRODUCT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293451 ↗
• InjuryJun 16, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT NEEDED TO HAVE A STENT REMOVED AFTER URETERAL LITHOTRIPSY AND LITHOTRIPSY FOR RENAL CALCULI. URETERAL STENT PLACEMENT TIME WAS 60 DAYS, AND THE SURGERY WAS PREPARED TO REMOVE THE URETERAL STENT, AND IT WAS FOUND THAT THE STENT WAS HEAVILY ENCRUSTED, AND THE STENT COULD NOT BE REMOVED SUCCESSFULLY. AFTER CLINICAL JUDGMENT, THE PATIENT CHOSE TO USE SURGICAL INTERVENTION TO REMOVE THE STENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE STENT WAS SUCCESSFULLY REMOVED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 22211115 ↗
• MalfunctionApr 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE INDWELLING URETERAL STENT WAS OPENED, IT WAS FOUND THAT THE PIG TAIL WAS BROKEN. THEY REPLACED WITH A NEW INDWELLING URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925642 ↗
• MalfunctionApr 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THEY FOUND THAT THE URETERAL STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773099 ↗
• MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE, REMOVED THE WIRE AND STRAIGHTENED IT, THEY FOUND THAT THERE WAS NO PIGTAIL PART AT THE OTHER END, AND THE REMAINING PART WAS FOUND IN THE PACKAGING TAPE. THE SOLUTION WAS TO REPLACE THE BRACKET WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364625 ↗
• MalfunctionFeb 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE AFTER UNPACKING THE URETERAL STENT, THEY FOUND THAT THE HEAD OF THE STENT WAS BROKEN AND COULD NOT BE USED. THEY OPENED A NEW STENT AND USED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332652 ↗
• MalfunctionJan 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT IT SEEMS THAT THE SURFACE OF INLAY URETERAL STENT WAS TOO DRY. IT WAS TOO HARD TO INSERT STENT WHEN INSERTING PATIENT BODY. PHYSICIAN FELT THAT IT WAS TOO HARD TO INSERT STENT WHEN INSERTING PATIENT'S BODY. (LOT#NGJS2407) AND (LOT#NGJR2318).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167674 ↗