Bard InLay Optima Ureteral StentRecalls & reported problems across all models

We found 21 models of Bard InLay Optima Ureteral Stent by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 338 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2017 and Sep 28, 2026 — classified as 76 injuries, 262 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (153 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bard InLay Optima Ureteral Stent recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 6, 2025Open, Classified

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

   Z-0908-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 6, 2025Open, Classified

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

   Z-0907-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Nov 6, 2025Open, 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 Bard InLay Optima Ureteral Stent problems

Bard InLay Optima Ureteral Stent models

21 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® InLay Optima® Ureteral Stent 788426

  STENT, URETERAL
  1 recall100 reports
• Bard® InLay Optima® Ureteral Stent 788626

  STENT, URETERAL
  122 reports
• Bard® InLay Optima® Ureteral Stent 788826

  STENT, URETERAL
  1 recall2 reports
• Bard® InLay Optima® Ureteral Stent 788630

  STENT, URETERAL
  1 recall1 report
• Bard® InLay Optima® Ureteral Stent 788624

  STENT, URETERAL
  38 reports
• Bard® InLay Optima® Ureteral Stent 788726

  STENT, URETERAL
  17 reports
• Bard® InLay Optima® Ureteral Stent 788414

  STENT, URETERAL
  11 reports
• Bard® InLay Optima® Ureteral Stent 788424

  STENT, URETERAL
  9 reports
• Bard® InLay Optima® Ureteral Stent 788622

  STENT, URETERAL
  9 reports
• Bard® InLay Optima® Ureteral Stent 788628

  STENT, URETERAL
  9 reports
• Bard® InLay Optima® Ureteral Stent 788614

  STENT, URETERAL
  4 reports
• Bard® InLay Optima® Ureteral Stent 788420

  STENT, URETERAL
  3 reports
• Bard® InLay Optima® Ureteral Stent 788814

  STENT, URETERAL
  3 reports
• Bard® InLay Optima® Ureteral Stent 788724

  STENT, URETERAL
  2 reports
• Bard® InLay Optima® Ureteral Stent 788824

  STENT, URETERAL
  2 reports
• Bard® InLay Optima® Ureteral Stent 788422

  STENT, URETERAL
  1 report
• Bard® InLay Optima® Ureteral Stent 788428

  STENT, URETERAL
  1 report
• Bard® InLay Optima® Ureteral Stent 788714

  STENT, URETERAL
  1 report
• Bard® InLay Optima® Ureteral Stent 788728

  STENT, URETERAL
  1 report
• Bard® InLay Optima® Ureteral Stent 788822

  STENT, URETERAL
  1 report
• Bard® InLay Optima® Ureteral Stent 788828

  STENT, URETERAL
  1 report

Recent Bard InLay Optima Ureteral Stent adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924430 ↗
• MalfunctionSep 18, 2026Use of Device Problem

  It was reported that after the stent was inserted, one suture was cut and pulled. During this process, the distal end was unintentionally withdrawn, resulting in complete stent dislodgement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818417 ↗
• MalfunctionSep 9, 2026Material Fragmentation

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

  MAUDE report 50692465 ↗
• 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 ↗
• MalfunctionJun 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, DOCTOR OPENED THE PACKAGE STERILE PACKAGING AND FOUND A HAIR INSIDE, CONCLUDING THAT THE PRODUCT WAS CONTAMINATED AND UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641976 ↗
• 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 ↗
• MalfunctionApr 4, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY CRITICAL CARE NURSES THAT IN AN ONLINE SURVEY A PHYSICIAN STATED THAT "NO HE OR SHE WAS NOT ABLE TO SUCCESSFULLY RELIEVE THE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE" BECAUSE "EXTERNAL COMPRESSION" REFERENCING PRODUCT CODE 788714, INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 7 FR, 14CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784430 ↗
• MalfunctionMar 30, 2026No Display/Image; Nonstandard Device

  IT WAS REPORTED THAT THE BEFORE USE IN THE SET OF INLAY OPTIMA STENT, PROVIDED PUSHER WAS TOO SHORT RELATIVE TO THE LENGTH OF THE URETERAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718709 ↗
• 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 ↗
• 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 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE GUIDEWIRE WAS ENTANGLEMENT DURING STENT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308752 ↗
• 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 ↗

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