Bard® InLay Optima® Ureteral Stent 788626Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741015762), received between May 2, 2018 and Mar 18, 2026 — classified as 29 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (60 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 122 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Calcified

  IT WAS REPORTED THAT PATIENT HAD A URETERAL STENT IN PLACE FOR 4 WEEKS PRESENTED WITH LOWER BACK PAIN AND CAME TO THE HOSPITAL FOR A FOLLOW-UP EXAMINATION. IT WAS FOUND THAT STONES HAD FORMED ON THE SURFACE OF THE STENT, SO THE STENT WAS REPLACED.

  Patient problems: Pain

  MAUDE report 24635141 ↗
• MalfunctionFeb 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING USE, IT WAS DISCOVERED THAT ONE END OF THE URETERAL STENT HAD BROKEN OFF AT THE PIGTAIL SECTION, RENDERING IT UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400295 ↗
• InjuryFeb 19, 2026Calcified; Difficult to Remove

  IT WAS REPORTED THAT, ON 09FEB2026, THE PATIENT UNDERWENT A CYSTOSCOPY STENT REMOVAL PROCEDURE TO EXTRACT THE STENT. AN URETERAL STENT HAD BEEN PLACED DURING A FLEXIBLE URETEROSCOPY LITHOTRIPSY PROCEDURE 180 DAYS PRIOR. DURING THE PLANNED REMOVAL, 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. SURGICAL INTERVENTION WAS SELECTED TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THE STENT WAS REMOVED WITHOUT INCIDENT, AND THERE WERE NO OTHER EFFECTS.

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

  MAUDE report 24394223 ↗
• InjuryJan 23, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED PERSISTENT FEVER THREE WEEKS AFTER URETERAL STENT PLACEMENT. THE FEVER SUBSIDED AFTER REPLACEMENT WITH A NEW STENT AT THE HOSPITAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Fever

  MAUDE report 24172905 ↗
• MalfunctionDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DOUBLE J URETERAL STENT WAS FRACTURED AT THE CURLED END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796977 ↗
• InjuryNov 5, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPIC LITHOTRIPSY FOR KIDNEY STONES. THE PATIENT ALSO HAD STRICTURE, AND A URETERAL STENT (788626) WAS PLACED DURING THE PROCEDURE. THREE MONTHS AFTER STENT PLACEMENT, IT BECAME DIFFICULT TO REMOVE, AND UPON REMOVAL, IT WAS FOUND TO BE COVERED WITH STONES. SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT, AND SUBSEQUENT PROCEDURES SUCCESSFULLY REMOVED IT, COMPLETING THE SURGERY SMOOTHLY. NO ACTUAL SAMPLES OR PHOTOGRAPHS WERE AVAILABLE AT THIS TIME.

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

  MAUDE report 23480157 ↗
• MalfunctionNov 4, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE CUSTOMER NOTED THAT THE STENT WAS "STICKY" AND COULD NOT ADVANCE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16JAN2026, IT WAS REPORTED THAT THE ADDITIONAL STENT HAD TO BE OPENED AND USED ON THE PATIENT. DEVICE WAS NOT REPAIRED. PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467939 ↗
• MalfunctionAug 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT; URETERAL STENT MODEL NUMBER 788626 WAS USED ON (B)(6) 2025. UPON OPENING THE PACKAGE, IT WAS FOUND DURING INSTALLATION THAT ONE OF THE STENTS WAS BROKEN AND UNUSABLE. THE HOSPITAL CONTACTED COMPANY ON THE SAME DAY, AND PROVIDED DETAILED INFORMATION TO THE COMPANY ON (B)(6) 2025, REQUESTING FOR A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804273 ↗
• MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE NURSE OPENED THE PACKAGE AND ACTIVATED THE COATING WITH SALINE, THEY CHECKED THE STENT FOR DUCTILITY AND FOUND THAT THE URETERAL STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739654 ↗
• MalfunctionJul 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. WHEN THE PROCEDURE ENTERED THE CATHETERIZATION STAGE, THE URETERAL STENT WAS INSERTED. AFTER THE STENT WAS OPENED FROM ITS PACKAGE, THE STENT BROKE DURING INSERTION. THE SPECIFIC CAUSE OF THE BREAKAGE WAS UNKNOWN. THE UNIT HAD RICH CLINICAL OPERATION EXPERIENCE. THE CLINIC CHOSE TO OPEN A NEW PACKAGE, AND THE PRODUCT COMPLETED THE SUBSEQUENT OPERATIONS SMOOTHLY WITHOUT ANY PROBLEMS, AND THE OPERATION WAS COMPLETED SMOOTHLY. THE OPERATION WAS DELAYED, WITH NO OTHER IMPACT.

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

  MAUDE report 22483139 ↗
• MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, WHEN OPEN THE PACKAGE OF URETERAL STENT ON 09JUNE2025, THE INSIDE OF A STENT FOUND BROKEN, IT COULD NOT BE USED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322182 ↗
• MalfunctionJun 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER CRUSHING THE STONE, THE OPERATOR UNPACKED THE BOX WITHOUT ANY ABNORMALITY AND UNPACKED THE INNERMOST LAYER OF THE PACKAGE WITHOUT ANY ABNORMALITY, AND THEN CUT THE FILAMENT, AND WHEN THEY REMOVED THE PIGTAIL MODULATOR, THEY FOUND THAT THE URETERAL STENT WAS BROKEN, SO THE OPERATOR TERMINATED THE USE OF THAT ONE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12JUN2025, STATED THAT THE PATIENT NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298654 ↗
• MalfunctionJun 10, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE BOX WAS UNOPENED, BUT THE LID OF THE INSIDE BOX WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175279 ↗
• InjuryJun 2, 2025Calcified; Calcified

  IT WAS REPORTED THAT WHEN THE STENT WAS REMOVED AFTER 3 MONTHS IN THE PATIENT'S BODY, IT WAS FOUND THAT THE STENT HAD A SERIOUS STONE GROWTH, AND THE STENT WAS REMOVED BY HOLMIUM LASER LITHOTRIPSY, AND THE CUSTOMER COMPLAINED SERIOUSLY ABOUT THE STONE GROWTH OF THE STENT AND HOPED THAT THE COMPANY WOULD GIVE US AN EXPLANATION. IT SERIOUSLY AFFECTED THE TIME OF SURGERY AND ALSO HAS AN IMPACT ON THE PATIENT'S PROGNOSIS LATER IN LIFE. PATIENT HAS BEEN EXPOSED TO HAZARDOUS MATERIALS, BLOOD OR BODY FLUIDS.

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

  MAUDE report 22123560 ↗
• InjuryMay 27, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING URETERAL STENOSIS RETROGRADE PYELOGRAM, IT WAS CONFIRMED THAT THE TIP OF THE TIGER TAIL CATHETER HAD COME OFF. THE TIP WAS CONFIRMED BY FLUOROSCOPY. IT WAS REMOVED. PER ADDITIONAL INFORMATION RECEIVED ON 20MAY2025, STATED THAT THE TIP OF THE TIGER TAIL URETERAL CATHETER WAS SEVERED. FLUOROSCOPY WITH RP (URETERAL CONTRAST EXAMINATION) CONFIRMED THAT THE TIP HAD COME OFF AND REMAINED INSIDE THE BODY. OBSERVED WITH A URETEROSCOPE. REMOVED WITH RELIC FORCEPS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22088212 ↗
• MalfunctionMay 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS SOLD TO (B)(6) HOSPITAL BY OUR COMPANY ON (B)(6) 2025 AND ON (B)(6) 2025 IT WAS FOUND THAT THE STENT WAS DISCONNECTED AS SOON AS IT WAS OPENED WHEN IT WAS USED. THE HOSPITAL CONTACTED OUR COMPANY ON THE SAME DAY, AND WE ALSO FEEDBACK THE DETAILS WITH YOUR COMPANY AND ASKED THE OTHER PARTY TO GIVE THE SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026515 ↗
• 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 21892839 ↗
• 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 21890304 ↗
• InjuryMar 17, 2025Calcified; Calcified

  IT WAS REPORTED THAT LESS THAN A MONTH AFTER THE URETERAL STENT WAS PLACED, IT WAS FOUND THAT THE PIG'S TAIL WAS FULL OF STONES. THE PATIENT NEEDS TO BE READMITTED FOR HOLMIUM LASER LITHOTRIPSY AND THEN A NEW URETERAL STENT WAS PLACED.

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

  MAUDE report 21617986 ↗
• MalfunctionJan 23, 2025Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216827 ↗
• InjuryDec 27, 2024Calcified; Calcified

  IT WAS REPORTED THAT DUE TO LEFT URETERAL OBSTRUCTION, DOUBLE J TUBE STENT REPLACED REGULARLY. THE INSTRUCTIONS FOR THE BARD DOUBLE J TUBE DID NOT MATCH THE INSTRUCTIONS. THE INSTRUCTION STATED THAT IT COULD BE LEFT IN PLACE FOR 12 MONTHS. HOWEVER, AFTER 6 MONTHS OF INDWELLING, A HUGE STONE FORMED AT THE BLADDER END. USED FOREIGN BODY FORCEPS TO CRUSH THE STONES. DURING THE CRUSHING PROCESS, ONE OF THE CYSTOSCOPE FOREIGN BODY FORCEPS WAS DAMAGED AND COULD NOT BE USED. AFTER REMOVAL UNTIL THE URETHRAL CATHETER WAS INCARCERATED AGAIN, THE FOREIGN BODY FORCEPS WERE USED AGAIN TO CRUSH THE STONES. DURING THE CRUSHING PROCESS, ONE OF THE CYSTOSCOPE FOREIGN BODY FORCEPS WAS DAMAGED AGAIN AND THE URETHRA WAS OBVIOUSLY LACERATED. THE FOREIGN BODY FORCEPS COULD BE REPLACED BEFORE REMOVAL. AND THE PATIENT GOT URETHRA, BLADDER, URETERAL INJURY.

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

  MAUDE report 21026414 ↗
• MalfunctionDec 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN THE HOSPITAL OPENED THE STERILE PACKING, THEY FOUND THAT THE STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018678 ↗
• MalfunctionDec 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE URETERAL CATHETER ADAPTER WAS HARD. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 12DEC2024, CUSTOMER CONFIRMED THAT 3 PRODUCTS WERE AFFECTED AND PATIENT INVOLVEMENT. DEVICE WAS USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000491 ↗
• InjuryDec 20, 2024Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT WITH A REGULAR INDWELLING URETERAL STENT, THE STENT HAD BEEN REMOVED AFTER 5 MONTHS OF INDWELLING, WAS FOUND TO HAD STONES ATTACHED TO THE SURFACE OF THE STENT AT THE BLADDER END, WHICH MADE IT DIFFICULT TO REMOVE THE URETERAL STENT WITH A FOREIGN BODY LEAD. LATER, THE STENT WAS REMOVED BY LITHOTRIPSY UNDER ANESTHESIA. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10DEC2024, STATED THAT THERE WAS THE STONE ATTACHED TO THE STENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 17DEC2024, STATED THAT THE DIRECTOR SAW THAT THE STONE WAS ATTACHED TO THE SURFACE OF THE STENT AND COULD NOT BE PULLED OUT OF THE BODY, SO USED FOREIGN BODY FORCEPS TO PEEL OFF THE STONE ON THE SURFACE OF THE STENT.

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

  MAUDE report 20986669 ↗
• MalfunctionDec 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE URETERAL STENT PLACEMENT ENDED, AND THE PATIENT WAS DISCHARGED, BUT THE PATIENT HAD SEVERE REJECTION REACTION AND PERSISTENT PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 20951943 ↗