Bard® InLay Optima® Ureteral Stent with NiCore™ Guidewire 786426Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10801741015042), received between Jun 9, 2017 and May 7, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Calcified; Material Fragmentation

  IT WAS REPORTED THAT THE STENT WAS LEFT IN PLACE FOR TWO MONTHS AND BECAME COMPLETELY ENCRUSTED WITH CALCULI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113489 ↗
• MalfunctionDec 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT NEEDS TO BE PLACED ON THE PATIENT AFTER URETEROSCOPIC LITHOTOMY IN ORDER TO ELIMINATE THE OBSTRUCTION CAUSED BY VARIOUS BENIGN, MALIGNANT AND POST-TRAUMATIC CONDITIONS IN THE URETER. WHEN THE DOCTOR WAS PREPARED TO INSERT THE URETERAL STENT DURING THE OPERATION, THE STENT ITSELF WAS BLOCKED BY THE LABEL ON THE PACKAGE AND CANNOT BE SEEN AT ALL, AFTER THAT THE ITINERANT NURSE OPENED THE BAG, IT WAS FOUND THAT THE STENT SHAFT WAS BROKEN, AND THE SILK THREAD WAS ENTANGLED WITH THE STENT, SO THE PRODUCT CANNOT BE USED, RESULTING IN THE PROLONGATION OF THE OPERATION TIME. IN ORDER TO ENSURE THE COMPLETION OF THE OPERATION, THE SURGEON ASKED TO REOPEN AND PREPARE 2-3 SETS OF THE PRODUCT IN ADVANCE AND THEN PLACE IT, AND THE FOLLOW-UP OPERATION OF THE PATIENT WENT SMOOTHLY AND GRADUALLY RECOVERED.

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

  MAUDE report 21018299 ↗
• MalfunctionJan 10, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT WHEN THE USER OPENED THE 786426 BRACKET PACKAGE, THEY FOUND THAT IT WAS A 6F BRACKET INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484109 ↗
• MalfunctionNov 9, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER OPENED THE PACKAGE DURING THE OPERATION AND FOUND THAT THE STENT CATHETER WAS 426 MODEL, BUT THE PUSH TUBE WAS 626, WHICH COULD NOT BE MATCHED FOR NORMAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099931 ↗
• MalfunctionOct 27, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE 6FR BRACKET WAS INCLUDED IN THE 786426 (4.5FR * 26CM) BRACKET SETS. THERE WERE 15 UNOPENED SETS IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021570 ↗
• MalfunctionOct 20, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER FOUND THE URETERAL STENT DEFECTIVE DURING THE PROCEDURE. PER FOLLOW UP INFORMATION RECEIVED ON 05OCT2023, ACCORDING TO THE OPERATING THEATRE, PULLING THE CORD ALSO BROKE THE STENT. THE EVENT OCCURRED BEFORE THE STENT WAS INSERTED INTO THE PATIENT. A 2ND STENT HAS SINCE BEEN BROKEN IN A SIMILAR MANNER, A STENT WITH THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981586 ↗
• MalfunctionOct 10, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT WHEN IN USE DURING OPERATION, THE STENT WAS FOUND OCCLUDED SO THAT THE URINE COULD NOT BE DRAINED. AS PER THE FOLLOW UP INFORMATION RECEIVED VIA IBC ON 20SEP2023, THE URETERAL STENT WAS USED FOR LAPAROSCOPIC RIGHT URETERAL BLADDER REPLANTATION AND WAS REPLACED WITH A NEW STENT WHEN THE STENT WAS FOUND TO BE BLOCKED DURING INTRAOPERATIVE USE AND URINE COULD NOT BE DRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903904 ↗
• MalfunctionSep 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT FRACTURED WHEN IT WAS REMOVED FROM PIGTAIL MODULATOR AFTER UNPACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774098 ↗
• MalfunctionAug 2, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE URETERAL STENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441901 ↗
• MalfunctionJul 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT TUBING WAS FOUND TO BE RUPTURED UPON UNPACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423843 ↗
• MalfunctionJul 28, 2023Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE URETERAL STENT WAS BEING REMOVED FROM THE PIGTAIL MODULATOR AFTER OPENING THE PACKAGE, BREAKAGE OCCURRED WITH THE STENT. IT WAS STATED THAT THE ADDITIONALLY, EVIDENT SIGNS OF CREASE WERE FOUND AT THE STENT TUBING PIGTAIL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413083 ↗
• MalfunctionJul 26, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WERE FIVE PRODUCTS OF 786426 THAT 6 FR STENTS WAS CONTAINED IN. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 14JUL2023, CLARIFIED THAT IT WAS A WRONG PRODUCT IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396038 ↗
• MalfunctionJul 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THE URETERAL STENT TUBING WAS RUPTURED WHEN THE PIGTAIL STRAIGHTENER WAS USED TO STRAIGHTEN THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342154 ↗
• MalfunctionJul 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THE URETERAL STENT TUBING WAS RUPTURED WHEN THE PIGTAIL STRAIGHTENER WAS USED TO STRAIGHTEN THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341913 ↗
• MalfunctionJul 5, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING OF THE PACKAGE, THE STENT TUBING WAS FOUND RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256377 ↗
• MalfunctionApr 13, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THE PACKAGE OF 786426 URETERAL STENT WAS NOT OPENED. THE SIZE OF THE STENT INSIDE WAS 6FR. THERE WERE A TOTAL OF 6 STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731621 ↗
• MalfunctionMar 31, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THERE WAS A URETERAL STENT OF FRENCH SIZE SIX INSIDE THE KIT UPON OPENING. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 29MAR2022, IT WAS STATED THAT EACH HOSPITAL RECEIVED ONE PRODUCT. THE SAMPLES RECEIVED HAD ENGRAVED 6FR ON THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655228 ↗
• MalfunctionMar 31, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS FOUND TO BE RUPTURED UPON OPENING THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655116 ↗
• MalfunctionMar 31, 2023Inadequate Instructions for Healthcare Professional; Wrong Label; Inadequate Instructions for Healthcare Professional; Wrong Label

  IT WAS REPORTED THAT THERE WAS A URETERAL STENT OF FRENCH SIZE SIX INSIDE THE KIT UPON OPENING. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2022, IT WAS STATED THAT THE EACH HOSPITAL RECEIVED ONE PRODUCT. IT WAS ALSO STATED THAT THE SAMPLES RECEIVED HAD ENGRAVED 6FR ON THE STENT. THE SEQUENCE NUMBER PRINTED ON THE UNIT LABEL OF THE POUCH LIKE THE ONE (02137) ON THE FOUR COMPLAINTS LIKE 02292. THE FRENCH SIZE ON THE STENT INSIDE THE POUCH WITH LABEL NUMBER 02137 COULD NOT BE NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655114 ↗
• MalfunctionMar 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WERE 3 URETERAL STENTS HAD THE SAME ISSUE IN THE SAME OPERATION. AFTER OPENING THE PACKAGE, THE STENT COULD NOT BE ADVANCED. IT WAS MENTIONED THAT THERE WERE NO OTHER COMPLICATIONS. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, IT WAS STATED THAT ALL THREE STENTS WERE BELONGING TO THE SAME LOT. AS PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON (B)(6) 2023, IT WAS STATED THAT THE USER RETURNED THREE USED SAMPLES. IT WAS STATED THAT WHEN THE SAMPLES WERE EVALUATED BY THE SUPPLIER, THEY WERE CONFIRMED TO HAVE BEEN USED. IT WAS ALSO STATED THAT ONE OF THE STENTS WAS OBSERVED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635217 ↗
• MalfunctionMar 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WERE 3 URETERAL STENTS HAD THE SAME ISSUE IN THE SAME OPERATION. AFTER OPENING THE PACKAGE, THE STENT COULD NOT BE ADVANCED. IT WAS MENTIONED THAT THERE WERE NO OTHER COMPLICATIONS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02NOV2022, IT WAS STATED THAT ALL THREE STENTS WERE BELONGING TO THE SAME LOT. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON 07MAR2023, IT WAS STATED THAT THE USER RETURNED THREE USED SAMPLES. IT WAS STATED THAT WHEN THE SAMPLES WERE EVALUATED BY THE SUPPLIER, THEY WERE CONFIRMED TO HAVE BEEN USED. IT WAS ALSO STATED THAT ONE OF THE STENTS WAS OBSERVED TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635107 ↗
• MalfunctionNov 10, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 15 DAYS AFTER THE PATIENT'S URETERAL STENT IMPLANTATION, THE URETERAL STENT WAS FOUND TO BE BROKEN DURING URETERAL STENT REMOVAL UNDER LOCAL ANESTHESIA IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770355 ↗
• MalfunctionNov 6, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS FOUND TO BE RUPTURED UPON OPENING THE PACKAGE. IT WAS MENTIONED THAT FOUR QUANTITIES WERE AFFECTED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02NOV2022, IT WAS STATED THAT ONLY ONE STENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741326 ↗
• MalfunctionNov 6, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WERE 3 URETERAL STENTS HAD THE SAME ISSUE IN THE SAME OPERATION. AFTER OPENING THE PACKAGE, THE STENT COULD NOT BE ADVANCED. IT WAS MENTIONED THAT THERE WERE NO OTHER COMPLICATIONS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 02NOV2022, IT WAS STATED THAT ALL THREE STENTS WERE BELONGING TO THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741322 ↗
• MalfunctionSep 16, 2022Calcified; Calcified

  IT WAS REPORTED THAT PLENTY OF CALCULI WERE OBSERVED TWO WEEKS AFTER THE URETERAL STENT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437816 ↗