Bard® InLay® Ureteral Stent 778424Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741014758), received between Jun 29, 2017 and Aug 6, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Calcified; Calcified

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPIC LITHOTRIPSY FOR KIDNEY STONES AND NEEDED A STENT REMOVAL. THE STENT HAD BEEN IN PLACE FOR 20 DAYS. DURING THE PROCEDURE TO REMOVE THE URETERAL STENT, SEVERE ENCRUSTATION OF THE STENT WAS OBSERVED, MAKING IT DIFFICULT TO REMOVE. AFTER CLINICAL EVALUATION, SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE STENT WAS REMOVED. INCREASING THE DURATION AND COST OF THE PROCEDURE.

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

  MAUDE report 22726537 ↗
• MalfunctionApr 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. WHEN THE PROCEDURE ENTERED THE CATHETERIZATION STAGE, THE URETERAL STENT WAS INSERTED. AFTER THE STENT WAS OPENED, A SMALL GAP WAS FOUND AT THE HEAD OF THE PIGTAIL OF THE STENT WHEN THE STENT WAS INSERTED (ACTUAL SAMPLES AND PHOTOS CAN BE SEEN). AFTER CLINICAL JUDGMENT, A NEW PACKAGE WAS CHOSEN. THE PRODUCT COMPLETED THE SUBSEQUENT OPERATIONS SMOOTHLY WITHOUT ANY PROBLEMS, AND THE OPERATION WAS COMPLETED SMOOTHLY. THE OPERATION WAS DELAYED, AND THERE WERE NO OTHER IMPACTS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 03APR2025, STATED THAT THE PATIENT DID NOT USE THE PRODUCT, AND THE QUALITY ISSUE WITH THE STENT WAS DISCOVERED BEFORE THE STENT WAS INSERTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805056 ↗
• MalfunctionDec 28, 2021Migration; Migration

  IT WAS REPORTED THAT THE STENT WAS FOUND IN THE ABDOMEN OUTSIDE THE URETER. THERE WAS A PIGTAIL CATHETER ADJACENT TO THE URETER. THIS WAS EXTERNAL TO THE URETER AND NOT IN BOWEL. CLINICAL CORRELATION WAS RECOMMENDED AND THIS HAS BEEN PLACED IN THE INTERVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13102512 ↗
• MalfunctionApr 15, 2020Material Fragmentation

  IT WAS REPORTED THAT UPON INSERTING URETERAL STENT PUSHER INTO NIPPLE ON 22F SHEATH, ORANGE SHAVINGS FROM PUSHER WAS OBSERVED AND REMOVED FROM BLADDER. IT WAS LATER REPORTED FROM THE SALES REP. VIA EMAIL ON 31MAR2020, THE DOCTOR LEFT THE SHEATH IN AND LET THE PIECES/SHAVINGS DRAIN OUT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 9962308 ↗
• MalfunctionJun 29, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE SUTURE LOOP BROKE AWAY FROM THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676615 ↗