Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787626Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10801741015448), received between May 28, 2019 and Sep 11, 2026 — classified as 11 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (24 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Accessory Incompatible

  It was reported that this event indicates that the stent was not sliding smoothly. Discontinue use due to strong resistance from the guidewire during insertion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734403 ↗
• MalfunctionMar 12, 2026Accessory Incompatible

  IT WAS REPORTED THAT WHEN PLACING A STENT, THE STENT DID NOT MOVE UP ALONG THE GUIDEWIRE, RESULTING IN AN ACCORDION PHENOMENON. THERE WAS NO SMOOTH STENT PLACEMENT IN THE CURRENT ACCORDION SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584752 ↗
• MalfunctionOct 29, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER OPENING IT AND USING IT FOR SURGERY, IT BROKE JUST BY TOUCHING IT, SO THE HEALTH PROFESSIONAL STOPPED USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415243 ↗
• MalfunctionOct 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, THERE WAS A HAIR STUCK IN THE OUTER SEAL OF THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317203 ↗
• MalfunctionOct 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE THE TIP PIGTAIL OF THE STENTS BROKE OFF SIMPLY BY THREADING THE GUIDEWIRE THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235956 ↗
• MalfunctionAug 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING THE USE OF THE URETERAL STENT, AFTER OPENING THE PACKAGING AND REMOVING THE STENT, IT WAS DISCOVERED THAT THE STENT COATING WAS ROUGH AND TIGHT, MAKING IT IMPOSSIBLE TO INSERT INTO THE BODY. THE HOSPITAL CONTACTED THEIR COMPANY ON THE SAME DAY, AND THEY PROVIDED DETAILED INFORMATION TO THE COMPANY ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904280 ↗
• MalfunctionAug 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE PIGTAIL OF THE URETERAL STENT HAD CRACKS, AND A REPLACEMENT STENT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741267 ↗
• MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, A UROLOGY PATIENT UNDERWENT URETEROLITHOTOMY. WHEN PLACING A URETERAL STENT, IT WAS FOUND THAT THE NEWLY OPENED URETERAL STENT WAS BENT, AND THE GUIDE WIRE COULD NOT PASS THROUGH. THE URETERAL STENT MIGHT BE AT RISK OF FRACTURE. A NEW URETERAL STENT WAS RANDOMLY REPLACED TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739691 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE OPERATION, THEY OPENED THE PACKAGE AND FOUND THAT STENT WAS BROKEN, AND THE THREAD WAS INTACT, SO THEY REPLACED IT WITH A NEW PRODUCT AND CONTINUED THE OPERATION. PATIENT EXPERIENCED DELAY IN SURGERY.

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

  MAUDE report 22168201 ↗
• InjuryMay 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING STENT USE THE BLACK TIP, END POINT CAME OFF AND FELL INTO THE URETER DURING INSERTION OF THE URETERAL CATHETER. AS PER ADDITIONAL INFORMATION RECEIVED ON 21APR2025, IT WAS RETRIEVED IMMEDIATELY DURING SURGERY, SO NO ADDITIONAL PROCEDURES WERE PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22070675 ↗
• MalfunctionApr 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER FOUND THAT THE STENT WAS BROKEN WHEN THEY UNPACKED THE PACKAGE BEFORE THE OPERATION. THEY THEN UNPACKED THE PACKAGE, TOOK PHOTOS AND SENT THEM TO THE MANUFACTURER TO FILE A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848915 ↗
• MalfunctionApr 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING URETERAL FLEXIBLE LITHOTRIPSY, PRIOR TO PLACEMENT OF THE LEFT URETER, THE OPTIMA PACKING STENT WAS OPENED AND FOUND TO BE BROKEN AND UNUSABLE, SO THE NEW OPTIMA STENT WAS REOPENED TO COMPLETE THE PLACEMENT OF THE TUBE STAY. THE SURGERY WAS PROLONGED AND THERE WAS A DELAY IN SURGERY.

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

  MAUDE report 21751532 ↗
• MalfunctionMar 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT FOLDED STENT WAS OBSERVED DURING INSERTION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 17FEB2025, CUSTOMER CONFIRMED THAT 2 PRODUCTS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503458 ↗
• MalfunctionFeb 14, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHEN THE STENT WAS OPENED, THERE WERE TWO KINK MARKS NEAR THE COIL ON ONE SIDE, SO IT WAS REFRAINED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21388092 ↗
• MalfunctionDec 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER INSERTING THE STENT ALONG WITH THE GUIDE WIRE, WHEN THE THREAD WAS PULLED TO REMOVE IT, THE TIP BROKE AND FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988698 ↗
• MalfunctionDec 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT GUIDEWIRE TIP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832917 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TRANSURETHRAL URETERAL STENT PLACEMENT IN OUR HOSPITAL ON (B)(6) DUE TO URETERAL STONES. ON (B)(6), PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INTERMITTENT RIGHT-SIDE LOW BACK PAIN, DARK URINE, AND SLIGHT DISCOMFORT DURING URINATION. URINALYSIS SHOWED URINARY TRACT INFECTION, AND THE URETERAL STENT WAS REMOVED ON (B)(6). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR URETERAL STENT PLACEMENT IN HOSPITAL FOR (LEFT) DUE TO URETERAL STONES ON 04SEP. THE PATIENT HAD EXPERIENCED SLIGHTLY FREQUENT URINATION AND URGENCY, OCCASIONAL GROSS HEMATURIA, AND LEFT LOW BACK PAIN, AND AFTER VISITING THE HOSPITAL ON THE (B)(6). THE DOCTOR TOOK OUT THE URETERAL STENT, GAVE ANTI-INFECTION TREATMENT, AND WAS DISCHARGED AFTER CURE, AND THE DOCTOR ORDERED THE PATIENT TO FOLLOW UP REGULARLY IN THE LATER STAGE.

  Patient problems: Hematuria; Micturition Urgency; Pain; Urinary Frequency / Polyuria

  MAUDE report 20797495 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE ON 4SEP, THE PATIENT UNDERWENT TRANSURETHRAL URETERAL STENT IMPLANTATION LEFT IN THE HOSPITAL DUE TO URETERAL STONES, AND ON 7OCT, PATIENT WAS ADMITTED TO THE HOSPITAL FOR SLIGHT FREQUENT URINATION AND URGENCY, OCCASIONAL GROSS HEMATURIA, AND INTERMITTENT LEFT LOW BACK PAIN, AND THE URETERAL STENT WAS REMOVED ON 8OCT.

  Patient problems: Hematuria; Micturition Urgency; Pain

  MAUDE report 20757060 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TRANSURETHRAL URETERAL STENT PLACEMENT IN OUR HOSPITAL ON (B)(6) DUE TO URETERAL STONES. ON (B)(6) PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INTERMITTENT RIGHT-SIDE LOW BACK PAIN, DARK URINE, AND SLIGHT DISCOMFORT DURING URINATION. URINALYSIS SHOWED URINARY TRACT INFECTION, AND THE URETERAL STENT WAS REMOVED ON (B)(6). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE URETERAL STENT PLACEMENT IN HOSPITAL FOR (LEFT) URETHRAL URETERAL STENT PLACEMENT DUE TO URETERAL STONES ON (B)(6). THE PATIENT HAD EXPERIENCED SLIGHTLY FREQUENT URINATION AND URGENCY, OCCASIONAL GROSS HEMATURIA, AND LEFT LOW BACK PAIN, AND AFTER VISITING THE HOSPITAL ON THE (B)(6). THE DOCTOR TOOK OUT THE URETERAL STENT, GAVE ANTI-INFECTION TREATMENT, AND WAS DISCHARGED AFTER CURE, AND THE DOCTOR ORDERED THE PATIENT TO FOLLOW UP REGULARLY IN THE LATER STAGE.

  Patient problems: Discomfort; Hematuria; Pain; Urinary Tract Infection

  MAUDE report 20745691 ↗
• MalfunctionNov 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN WHEN THEY PUT IT IN WATER BEFORE USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695074 ↗
• MalfunctionNov 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING USE, IT WAS FOUND THAT THE TIP OF THE GUIDEWIRE WAS BENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18SEP2024, CONFIRMED THAT NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620266 ↗
• MalfunctionSep 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE STENT WAS OPENED, IT WAS FOUND THAT THE HEAD END WAS DAMAGED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2024, STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278270 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER DISASSEMBLED THE STENT AND CUT OFF THE WIRE FIRST, THE BRACKET BROKE WHEN THE FORCE WAS APPLIED DURING THE MOUNTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587456 ↗
• MalfunctionApr 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A URETERAL STENT WAS REQUIRED DURING THE OPERATION. AFTER OPENING THE PACKAGE, THE DOCTOR TOOK OUT THE URETERAL STENT AND PULLED OUT THE BLACK LINE OF THE URETERAL STENT. THEY FOUND THAT THE URETERAL STENT WAS BROKEN AND PROMPTLY REPLACED IT WITH A NEW URETERAL STENT WITHOUT CAUSING ANY CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116535 ↗
• MalfunctionApr 4, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE APPEARANCE OF THE URETERAL STENT WAS NORMAL, THERE WAS NO OBVIOUS DIFFERENCE, THE HEAD END AND THE BRACKET WERE CONNECTED, AFTER OPENING THE BRACKET PACKAGE, THE HEAD END WAS DIRECTLY BROKEN AFTER THE HEAD END WAS STRAIGHTENED, AND OTHER BRACKETS WERE REPLACED, AND THE BRACKET WAS NOT USED TO THE HUMAN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041626 ↗