Bard® InLay Optima® Multilength Ureteral Stent 788600Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741015717), received between Apr 18, 2017 and Jun 25, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, WATER WAS MIXED INTO THE GUIDEWIRE OF THE STENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328901 ↗
• MalfunctionJun 10, 2025Fracture; Tear, Rip or Hole in Device Packaging; Fracture; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE URETERAL STENT WAS UNOPENED, BUT THE LID OF THE BOX INSIDE THE PLASTIC WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177593 ↗
• MalfunctionDec 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STENT BROKE WHEN THE THREAD WAS PULLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968082 ↗
• InjuryNov 23, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX ,PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS, STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema; Unspecified Infection

  MAUDE report 12862758 ↗
• MalfunctionNov 23, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX, PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS, STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862611 ↗
• MalfunctionNov 23, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX, PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS. STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862484 ↗
• MalfunctionNov 23, 2021Migration; Migration

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX, PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS, STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862482 ↗
• MalfunctionNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX, PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS. STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862479 ↗
• MalfunctionNov 23, 2021Calcified; Calcified

  IT WAS REPORTED THAT THE USER EXPERIENCED EDEMA, URETERAL REFLUX, PAIN/DISCOMFORT, HYDRONEPHROSIS, INFECTION, URINARY SYMPTOMS. STONE FORMATION, STENT DISLODGEMENT, MIGRATION, OCCLUSION, STENT ENCRUSTATION WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12862478 ↗
• InjuryNov 9, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFECTION WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE PAIN, DISCOMFORT, AND INFECTION.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 12779980 ↗
• InjurySep 11, 2019Break; Failure to Advance; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AS THE DOCTOR WAS PLACING THE STENT, THE STENT ¿ACCORDIANED¿ ON THE WIRE WHILE ADVANCING WITHIN THE URETER. THE STENT WAS COMPLETELY STUCK IN THE WIRE AND THE DOCTOR COULD NOT ADVANCE THE STENT OR REMOVE IT. THE DOCTOR COULDN¿T RECANNULATE THE PATIENT TO PUT IN ANOTHER STENT. SEVERAL ATTEMPTS WERE MADE TO PULL THE WIRE OUT OF THE STENT, AND IT WOULD NOT DISENGAGE. THE WIRE WAS REMOVED ONLY HALFWAY THROUGH THE STENT, AND PART OF THE STENT WAS CUT. THE TIP OF THE STENT THAT WAS CUT OFF WAS IN THE BLADDER. THE REMOVAL OF THE STENT AND WIRE CAUSED SWELLING AND BLEEDING. THE DOCTOR LOST ACCESS. THE PATIENT WAS THEN TAKEN TO INTERVENTIONAL RADIOLOGY WHERE A NEPHROSTOMY TUBE AND ANTEGRADE STENT WAS PLACED. THE PATIENT EXPERIENCED FEVERS AND BLOOD LOSS FOLLOWING THE INTERVENTIONAL PROCEDURES. PLATELETS WERE GIVEN DUE TO BLOOD LOSS.

  Patient problems: Blood Loss; Edema; Fever; Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Swelling

  MAUDE report 8992873 ↗
• MalfunctionApr 18, 2017Break

  IT WAS REPORTED THAT THE DEVICE FELL APART RIGHT OUT OF THE BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6500816 ↗