Bard® InLay Optima® Ureteral Stent 788424Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741015670), received between Feb 14, 2018 and Sep 28, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, 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 ↗
• 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 ↗
• MalfunctionJan 23, 2026Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER STATED THAT A DOUBLE J URETERAL STENT, 24 CM, 4.7 FR, PART NUMBER 788424, BROKE DURING INSERTION. THEY DID NOT HAD THE PART IN STOCK, BUT THEY COULD ORDER IT FOR THE CUSTOMER. ADDITIONAL INFORMATION RECEIVED ON 19 JAN 2026, STATED THAT NO IMPACT TO THE PATIENT HEALTH. IT WAS JUST BEING PUT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172974 ↗
• InjuryNov 7, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPIC LITHOTRIPSY FOR KIDNEY STONES, DURING WHICH A URETERAL STENT (788424) WAS PLACED. ONE MONTH AFTER STENT PLACEMENT, THE STENT BECAME DIFFICULT TO REMOVE, AND UPON REMOVAL, A STONE WAS FOUND INSIDE THE STENT. SURGICAL INTERVENTION WAS CHOSEN TO REMOVE THE STENT, WHICH WAS SUCCESSFULLY PERFORMED, AND THE SURGERY WAS COMPLETED 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 23497744 ↗
• MalfunctionMay 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BOTH PIGTAILS OF STENT HAD BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496131 ↗
• MalfunctionApr 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL RIGHT URETERAL STENT REMOVAL ON (B)(6) 2021, DURING WHICH RIGHT URETERAL EDEMA AND URETERAL STRICTURE WERE OBSERVED, AS WELL AS A LARGE NUMBER OF STONES ATTACHED TO THE DOUBLE TUBE. STATED THAT IT MADE DIFFICULTY IN EXTUBATION OF THE CATHETER AND FURTHER URETHRAL MUCOSAL INJURY AND BLEEDING. AFTER ACTIVE TREATMENT AFTER SURGERY, THE PATIENT WAS OBSERVED TO HAVE A GOOD RECOVERY.

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

  MAUDE report 11754210 ↗
• MalfunctionApr 19, 2021Positioning Failure; Physical Resistance/Sticking; Positioning Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL OF THE STENT DID NOT RECOIL IN TO POSITION. STATED THAT AFTER PLACING THE STENT THE UROLOGIST USED IMAGE GUIDANCE TO CONFIRM THE POSITION OF THE PRODUCT AND NOTED THAT THE COIL WHICH HOLD THE STENT IN PLACE DID NOT RECOIL. CUSTOMER PROCEED WITH SECOND PLACEMENT AND SAME INCIDENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683814 ↗
• MalfunctionApr 3, 2019Break

  IT WAS REPORTED THAT THE COIL AT THE END OF THE URETERAL STENT WAS RIPPED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8477773 ↗
• InjuryFeb 14, 2018Break

  IT WAS REPORTED THAT THE STENT WIRE BROKE IN HALF AS IT WAS BEING INSERTED INTO THE PATIENT DURING SURGERY.

  Patient problems: No Information

  MAUDE report 7269410 ↗