Bard® InLay Optima® Ureteral Stent with NiCore™ Guidewire 786626Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10801741015127), received between Mar 8, 2021 and Aug 3, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Calcified

  It was reported that during use patient had the stent in place for less than two months when severe calculus buildup was discovered; the stent was removed endoscopically.

  Patient problems: Calcium Deposits/Calcification; Exposure to Body Fluids

  MAUDE report 50124265 ↗
• MalfunctionApr 11, 2026Inadequacy of Device Shape and/or Size

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE/SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "MARKED OBSTRUCTION", REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM. ALSO STATED THAT "NO THE GUIDEWIRE DID NOT SUPPORT STENT PLACEMENT PROCEDURE" BECAUSE "OVERLY NARROW URETERS". REFERENCING PRODUCT CODE 786626 - INLAY OPTIMA URETERAL STENT WITH NICORE GUIDEWIRE, 6 FR, 26CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850171 ↗
• InjuryApr 8, 2026Calcified

  IT WAS REPORTED THAT THE URETERAL STENT HAD BEEN IN PLACE FOR OVER A MONTH, AND IT IS ALMOST COMPLETELY COVERED WITH STONES AND HOSPITALIZED TO REPLACE THE IMPLANTED STENT. THE PATIENT WAS ALSO EXPOSED TO BODILY FLUID.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24820776 ↗
• MalfunctionMay 10, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PATIENT UNDERWENT URETERAL STENT PLACEMENT IN THE OPERATING ROOM, NEEDED TO USE A 6F URETERAL STENT, USED A 786626 STENT SET DURING THE OPERATION, AND AFTER INSERTING THE GUIDEWIRE, OPENED THE STENT PACKAGE AND FOUND THAT THE STENT WAS A 4.7F STENT, SO IT COULD NOT BE USED, AND THEN REPLACED WITH A NEW STENT AND CONTINUED TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285782 ↗
• MalfunctionDec 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ON (B)(6) 2023, (B)(6) HOSPITAL PERFORMED URETEROSCOPY LITHOTRIPSY UNDER GENERAL ANESTHESIA TO REMOVE STONES, WHICH REQUIRED THE USE OF A URETERAL STENT, WHICH WAS RETURNED TO THE SUPPLIER AS IT WAS FOUND TO BE DAMAGED AND UNUSABLE WHEN IT WAS OPENED FOR PREPARATION BY THE ROVING NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300552 ↗
• MalfunctionNov 28, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT AFTER INVESTIGATION, THERE WERE 3 SETS OF 786626 WHERE THE PACKAGING DID NOT MATCH WITH THE ACTUAL PRODUCT INSIDE, WHICH WAS 4.7FR BRACKETS. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 14NOV2023, THE PACKAGE INCLUDES A NITINOL GUIDEWIRE AND A 4.7FR BRACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220416 ↗
• MalfunctionSep 5, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT AFTER OPENING THE OUTER PACKAGE AND WHEN PREPARING FOR THE SURGERY, THE DIAMETER OF THE URETERAL STENT WAS FOUND INCONSISTENT WITH THAT ON THE OUTER PACKAGE. STATED THAT THERE WAS A SURGICAL DELAY.

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

  MAUDE report 17682090 ↗
• MalfunctionAug 25, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT A URETHRAL STENT WAS REQUIRED WHEN PERFORMING URETEROSCOPIC LITHOTRIPSY UNDER GENERAL ANESTHESIA AT THE HOSPITAL ON (B)(6) 2023. WHEN PREPARING THE ITEMS, THE NURSE FOUND THAT THE MODEL OF THE BARD INLAY OPTIMA URETERAL STENT WAS LABELED AS 786626. BUT AFTER UNPACKING, THE DIAMETER OF THE CONTENT STENT WAS SHOWN AS 4.7 F, INCONSISTENT WITH THAT ON THE OUTER PACKAGE, STENT WAS USED. THE AGENT INSPECTED THE GOODS IN THIS LOT NUMBER AND FOUND NINE STENTS HAVING THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623314 ↗
• MalfunctionJul 18, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT WHEN PLACING THE URETERAL STENT ON (B)(6) 2023, THE DIRECTOR AND PROFESSOR INSPECTED THE OUTER PACKAGE OF THE CORRESPONDING MODEL AND FOUND NO PROBLEM WITH IT. UPON OPENING OF THE PACKAGE, THEY FOUND THAT THE STENT MODEL WAS INCONSISTENT WITH THAT LABELED ON THE OUTER PACKAGE. ANOTHER MODEL WAS THEN OPENED AND STILL INCONSISTENT WITH THAT ON THE OUTER PACKAGE (BATCH# NGGU1616). SUBSEQUENTLY, THE NURSE WAS ASKED TO OPEN THE PACKAGE OF THE REMAINING PRODUCTS AND FOUND ONE MORE UNIT THAT WAS LABELED WITH A MODEL INCONSISTENT WITH THE ACTUAL ONE ON THE OUTER PACKAGE (BATCH# NGGV0729). A TOTAL OF THREE UNITS THAT WERE LABELED WITH A MODEL INCONSISTENT WITH THE ACTUAL ONE ON THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343024 ↗
• MalfunctionJul 18, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT WHEN PLACING THE URETERAL STENT ON (B)(6) 2023, THE DIRECTOR AND PROFESSOR INSPECTED THE OUTER PACKAGE OF THE CORRESPONDING MODEL AND FOUND NO PROBLEM WITH IT. UPON OPENING OF THE PACKAGE, THEY FOUND THAT THE STENT MODEL WAS INCONSISTENT WITH THAT LABELED ON THE OUTER PACKAGE. ANOTHER MODEL WAS THEN OPENED AND STILL INCONSISTENT WITH THAT ON THE OUTER PACKAGE (BATCH# NGGU1616). SUBSEQUENTLY, THE NURSE WAS ASKED TO OPEN THE PACKAGE OF THE REMAINING PRODUCTS AND FOUND ONE MORE UNIT THAT WAS LABELED WITH A MODEL INCONSISTENT WITH THE ACTUAL ONE ON THE OUTER PACKAGE (BATCH# NGGV0729). A TOTAL OF THREE UNITS THAT WERE LABELED WITH A MODEL INCONSISTENT WITH THE ACTUAL ONE ON THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342625 ↗
• MalfunctionJul 10, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT ON (B)(6) 2023, A URETHRAL STENT WAS NEEDED. WHEN PREPARING THE SUPPLIES, THE NURSE FOUND THAT THE BARD INLAY OPTIMA URETERAL STENT INDICATED THE MODEL OF 786626, BUT THE STENT INSIDE THE PACKAGE HAD A DIAMETER (4.7F) DIFFERENT FROM THAT SHOWN ON THE OUTER PACKAGE. DUE TO THE CONCERN ABOUT THE PATIENT¿S SAFETY, THE STENT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290153 ↗
• MalfunctionMay 24, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THE OUTER PACKAGE OF THE THREE UNITS OF 786626 WERE INSPECTED AND NO ABNORMALITY WAS FOUND. THESE UNITS WERE THEN UNPACKED AND FOUND TO BE 4.7 F STENTS (26 CM), INCONSISTENT WITH THE MODEL 786626 ON THE OUTER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992945 ↗
• MalfunctionMay 8, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DIRECTOR & PROFESSOR IMPLANTED THE URETERAL STENT ON (B)(6) 2023. THE INSPECTION SHOWED NO ABNORMALITY WITH THE OUTER PACKAGE. THE PACKAGE WAS OPENED AND THE URETERAL STENT WAS PLACED. WHEN ADJUSTING THE POSITION OF THE STENT, IT RUPTURED SUDDENLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886185 ↗
• InjuryOct 28, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, URETERAL REFLUX, PAIN AND DISCOMFORT, STENT ENCRUSTATION AND URINARY SYMPTOMS WHILE USING URETHRAL STENTS. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 12715304 ↗
• InjuryOct 28, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION ,URETERAL REFLUX , PAIN AND DISCOMFORT, STENT ENCRUSTATION AND URINARY SYMPTOMS WHILE USING URETHRAL STENTS. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 12715255 ↗
• MalfunctionOct 28, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, URETERAL REFLUX, PAIN AND DISCOMFORT, STENT ENCRUSTATION AND URINARY SYMPTOMS WHILE USING URETHRAL STENTS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715150 ↗
• InjuryOct 28, 2021Calcified; Biocompatibility; Calcified; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, URETERAL REFLUX, PAIN AND DISCOMFORT, STENT ENCRUSTATION AND URINARY SYMPTOMS WHILE USING URETHRAL STENTS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR STONE FORMATION.

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

  MAUDE report 12714745 ↗
• MalfunctionSep 27, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE INLAY OPTIMA STENTS WERE MISSING, AND TWO BOXES WERE DELIVERED WITH ONLY A GUIDEWIRE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) ON (B)(6), IT WAS CONFIRMED THAT FROM EACH BOX 1 STENT, TOTAL 2 STENTS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536145 ↗
• MalfunctionSep 27, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE INLAY OPTIMA STENTS WERE MISSING, AND TWO BOXES WERE DELIVERED WITH ONLY A GUIDEWIRE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM IBC ON 08SEP2021, IT WAS CONFIRMED THAT FROM EACH BOX ONE STENT, TOTAL 2 STENTS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532961 ↗
• InjuryMar 8, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS. THE DOCTOR OBSERVED PATIENTS WHO RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN AND WAS FOUND WITH STENT ENCRUSTED IN LESS THAN 06 MONTHS. IT WAS ALSO STATED THIS HAPPENED TO MINIMUM 10 PATIENTS. PER FOLLOW UP VIA IBC ON 18FEB2021, THE PATIENT EXPERIENCED SYMPTOMS LIKE PAIN, URGE TO URINATE AND HEMATURIA AND HENCE, THE URGENT RETRIEVAL OF THE STENT WAS UNDERGONE IN OPERATION ROOM (OP) AND PLACED ANOTHER STENT FROM ANOTHER BRAND.

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

  MAUDE report 11441151 ↗
• InjuryMar 8, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE INLAY OPTIMA STENT WAS EXPECTED TO STAY IN A PATIENT FOR 356 DAYS, THE DOCTOR SAW PATIENTS WHO RETURNED TO HOSPITAL AFTER EXPERIENCING KIDNEY PAIN WAS FOUND WITH STENT ENCRUSTED IN LESS THAN 06 MONTHS. ALSO STATED THIS HAPPENED TO MINIMUM 10 PATIENTS AND STENT WAS BEING REMOVED. PER FOLLOW UP VIA IBC ON 18FEB2021, THE PATIENT EXPERIENCED SYMPTOMS LIKE PAIN, URGE TO URINATE AND HEMATURIA AND HENCE, THE URGENT RETRIEVAL OF THE STENT WAS UNDERGONE IN OPERATION ROOM (OP) AND PLACED ANOTHER STENT FROM ANOTHER BRAND.

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

  MAUDE report 11436751 ↗