Bard® Fluoro-4™ Silicone Ureteral Coil Stent 277406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741011754), received between Jul 23, 2018 and Jul 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING DIFFICULTIES WITH THE DOUBLE J (FLUOR 4- SILICONE URETERAL COIL STENT). THE ISSUE WAS NOTICED THROUGH THE PICTURES AND VIDEOS WHERE THE STENT WAS FOUND LIKE PLASTIC AND WAS TEARING DIRECTLY FROM THE BOX KNOWING THAT THE STENT WAS SUPPOSED TO BE STRETCHABLE FROM 23CM TO 30CM. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 28JUN2024, THE SAMPLE WAS AVAILABLE AND THEY CONFIRMED THAT THE SAMPLE WAS NOT USED BUT THE USER FOUND THE QUALITY OF THE PRODUCT CHANGES, SO TESTED IT BEFORE USING. THEY OPENED 5 ITEMS AND FOUND OUT BROKEN. 30 PIECES ARE STILL WITH THE PHARMACIST OF THE CLINIC AND THEY WOULD MAKE RETURN OF ALL THE SAMPLES FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700894 ↗
• InjuryMar 6, 2020Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem

  IT WAS REPORTED THAT THE FLUORO-4 SILICONE STENT WAS KNOTTED ON ONE END INSIDE THE PATIENT. THIS WAS FOUND DUE TO THE STENTS NOT DRAINING PROPERLY. THE UROLOGIST WAS ABLE TO REMOVE THE STENT AFTER CAREFUL RETRACTION. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL (B)(6) 2020, THE STENT WAS REMOVED FROM THE PATIENT USING A CYSTOSCOPY AND FORCEPS. NO ADDITIONAL INTERVENTION OR TREATMENT WAS REQUIRED ACCORDING TO THE UROLOGIST. THE UROLOGIST WAS ABLE TO SAFELY REMOVE THE STENT, WITH NO MAJOR INJURIES. HOWEVER SOME STONE FRAGMENTS CAUGHT BEHIND THE KNOT MIGHT HAVE CAUSED MINOR IRRITATION OF THE MUCOSA. NO SUPPLEMENTARY MEDICATION OR ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: Irritation; Patient Problem/Medical Problem

  MAUDE report 9801107 ↗
• MalfunctionJul 23, 2018Break

  IT WAS REPORTED THAT THE STENT WAS FOUND TO BE BROKEN BEFORE IT WAS USED ON THE PATIENT.

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

  MAUDE report 7710902 ↗