Bard® Fluoro-4™ Silicone Ureteral Stent 233724Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801741011716), received between Nov 9, 2021 and Apr 8, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Calcified” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054781 ↗
• MalfunctionApr 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051890 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE URETHRAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14046119 ↗
• MalfunctionApr 7, 2022Calcified; Calcified

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE STENT HAD ENCRUSTATION. ALSO, THE PATIENT HAD SURGICAL SITE INFECTION AND STENT DISLODGMENT. PATIENT ASKED WHY TO BELIEVE THE INFORMATION IN THE INSTRUCTIONS FOR USE (IFU) THAT DID NOT PROVIDE SUFFICIENT INFORMATION ABOUT THE PRODUCT AND ITS MEDICAL APPLICATION WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE URETHRAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14045344 ↗
• MalfunctionNov 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS BROKEN INTO THREE PIECES DURING REMOVAL. THE DEVICE WAS IMPLANTED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782465 ↗