Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777414Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741014441), received between Jul 21, 2021 and Feb 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (3 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.

• MalfunctionFeb 11, 2026Accessory Incompatible

  IT WAS REPORTED THAT DURING LAPAROSCOPIC PYELOPLASTY, THERE WAS SIGNIFICANT RESISTANCE WHEN ADVANCING THE URETERAL STENT ALONG THE HYDROPHILIC GUIDEWIRE, MAKING IT IMPOSSIBLE TO PASS; AND AFTER REPLACING IT, THE SURGERY PROCEEDED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314933 ↗
• MalfunctionFeb 11, 2026Accessory Incompatible

  IT WAS REPORTED THAT DURING LAPAROSCOPIC PYELOPLASTY, THE URETERAL STENT WAS PUSHED ALONG THE ULTRA-SLIP GUIDEWIRE WITH GREAT RESISTANCE AND CANNOT BE PASSED; AND THE SURGERY WENT SMOOTHLY AFTER THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314931 ↗
• MalfunctionFeb 11, 2026Accessory Incompatible

  IT WAS REPORTED THAT DURING LAPAROSCOPIC PYELOPLASTY, THERE WAS SIGNIFICANT RESISTANCE WHEN ADVANCING THE URETERAL STENT ALONG THE ULTRA-SMOOTH GUIDEWIRE, MAKING IT IMPOSSIBLE TO PASS; AND AFTER REPLACING IT, THE SURGERY PROCEEDED SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314359 ↗
• MalfunctionDec 9, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THREE YEARS AGO, THE PATIENT EXPERIENCED LOWER BACK PAIN DURING URINATION BUT DID NOT SEEK SPECIFIC TREATMENT. ABOUT 20 DAYS AGO, THEY DEVELOPED PAINLESS GROSS HEMATURIA THROUGHOUT URINATION WITHOUT ANY OBVIOUS CAUSED AND SOUGHT TREATMENT AT (B)(6) HOSPITAL OF (B)(6). SEEKING FURTHER DIAGNOSIS AND TREATMENT, THEY CAME TO THEIR HOSPITAL TODAY AND WAS ADMITTED TO THEIR DEPARTMENT WITH A DIAGNOSIS OF HYDRO NEPHROSIS WITH URETERAL STONES RIGHT URETERAL STONE, LEFT ADRENAL TUMOR, DIABETES, AND HYPERTENSION. FROM 13:40 TO 15:25 ON (B)(6) 2025, THE PATIENT UNDERWENT A LEFT ADRENAL TUMOR RESECTION IN THE RETROPERITONEAL CAVITY UNDER GENERAL ANESTHESIA. A URETERAL STENT WAS USED DURING THE SURGERY, BUT UPON OPENING THAT, THE PACKAGING WAS FOUND TO BE DAMAGED, RENDERING AND UNUSABLE. AFTER REPLACEMENT, THE SURGERY PROCEEDED SMOOTHLY. THAT INCIDENT OCCURRED DURING THE SURGICAL PROCEDURE AND NEGLECTED TO ADDRESS THAT AFTERWARD COULD EASILY LEAD TO SERIOUS HARM. THE PRODUCT ASEPTIC PACKAGING WAS DAMAGED (SEAL FAILURE), RENDERING THAT UNUSABLE. PRELIMINARY SPECULATION SUGGESTS THAT THE PRODUCT'S USAGE DATE (B)(6) 2025) WAS TOO FAR FROM ITS PRODUCTION DATE (B)(6) 2023), LEADI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764875 ↗
• MalfunctionJan 10, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE ON (B)(6) 2024, THE DIRECTOR OPENED THE PRODUCT PACKAGING AFTER CHECKING THAT THE OUTER PACKAGING WAS INTACT, TOOK OUT THE INNER PACKAGING OF THE PRODUCT MODEL 777414 URETERAL STENT, FOUND THAT THE BAG WAS DAMAGED AND WAS NOT IN A STERILE STATE, AND THE OPERATION COULD NOT BE COMPLETED. THE OPERATION WAS COMPLETED AFTER REPLACING IT WITH THE SAME PRODUCT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06JAN2025, STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124369 ↗
• MalfunctionOct 18, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE URETERAL STENT TUBE WAS NOT SMOOTH ENOUGH AND COULD NOT BE MOVED UP. ANOTHER STENT WAS USED TO COMPLETE THE OPERATION. THE PRODUCT WAS DISPOSED OF SINCE THE PATIENT HAD AN INFECTIOUS DISEASE, BY THE HOSPITAL AND SO THEY COULD NOT RETRIEVE THE SAMPLE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958060 ↗
• MalfunctionAug 7, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING PLACEMENT OF THE URETHRAL STENT BY THE DIRECTOR AND PROFESSOR ON (B)(6) 2023, THE PRODUCT WAS UNPACKED AFTER THE INSPECTION SHOWED THAT THE OUTER PACKAGE WAS INTACT. THE GUIDE WIRE COULD NOT BE INSERTED. THE HEAD NURSE WAS ASKED TO USE ANOTHER NEW BOX OF THE URETHRAL STENT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470816 ↗
• MalfunctionOct 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING THE STENT PACKAGE, THE PIGTAIL STRAIGHTENER WAS FOUND MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615480 ↗
• MalfunctionJul 21, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE STENT, THE USER FOUND THAT THE PUSHER WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202936 ↗