Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire 787624Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10801741015431), received between Jul 24, 2018 and May 22, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Material Fragmentation

  IT WAS REPORTED THAT WHEN A URINARY STENT WAS INSERTED, THE TIP OF THE TIGER TAIL CAME LOOSE AND FELL INTO THE URETER. IT WAS REPORTEDLY REMOVED VIA ENDOSCOPY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Insufficient Information

  MAUDE report 25260345 ↗
• MalfunctionDec 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE, THE STENT RUPTURED NEAR THE RENAL PELVIS LOOP; THE STENT BROKE WHEN THEY ATTEMPTED TO CUT THE SUTURES AND PULL IT OUT AFTER DEPLOYMENT. SINCE THE SUTURES ON THE BLADDER SIDE WILL BE CUT WITH SCISSORS, IT WAS UNLIKELY THAT THE SCISSORS WILL COME INTO CONTACT WITH THE RENAL PELVIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890474 ↗
• MalfunctionJul 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE END ACCESS URETERAL STENT GUIDE WIRE SHAFT WAS FRAYED, SO THE CUSTOMER DISCONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555626 ↗
• MalfunctionMar 27, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE STENT ENDS NEARLY TORN OFF AND THE PHYSICIAN WOULD ATTACH THE FILE LATER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 13MAR2025, CUSTOMER CONFIRMED THAT NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707832 ↗
• MalfunctionDec 16, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT CRACKS WERE FOUND IN STENTS DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938684 ↗
• MalfunctionOct 28, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE DURING USE, THE ADAPTER PART OF THE URETERAL STENT HAD BECOME STIFF AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545612 ↗
• MalfunctionSep 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DISCOVERED URETERAL STENT AFTER OPENING THE PACKAGE AND BEFORE USING IT. THE TIP WAS BENT SO REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309850 ↗
• MalfunctionSep 18, 2024Accessory Incompatible; Difficult to Remove; Accessory Incompatible; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE GUIDE WIRE WAS INSERTED INTO THE URETERAL STENT UP TO THE PIGTAIL ON THE KIDNEY SIDE, IT COULD NOT BE REMOVED FROM THE STENT. WHEN IT WAS REPLACED WITH ANOTHER STENT, THE GUIDE WIRE WAS REMOVED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245453 ↗
• MalfunctionAug 23, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE TIGER TAIL ADAPTER INCLUDED IN THE OPTIMA SET WAS TOO STIFF TO TURN. IT WAS SO STIFF THAT WHEN THEY TRIED TO MOVE IT BY HOLDING THE SHAFT AND PULLING IT HARD, THE SHAFT STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048577 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT BROKE OFF WHEN REMOVING THE STENT THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033405 ↗
• MalfunctionDec 15, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE QUALITY DEPARTMENT REPORTED FAILURE OF URETERAL STENT DURING THE LEFT ENDOSCOPIC URETEROLITHOTOMY PROCEDURE. WHEN ENTERING THE DOUBLE J CATHETER AND POSITIONING IT ON THE GUIDE, IT WAS EVIDENT THAT IT COULD NOT BE ADVANCED DESPITE HAVING THE EQUIPMENT AND THE GUIDE IN THE PROPER POSITION. IT WAS OBSERVED THAT THE DISTAL END FOLDS BACK ON ITSELF IN THE FORM OF AN ACCORDION. WHEN EXTRACTING THE CATHETER, IT SHOWS DETERIORATION AND ANGULATION OF THE SAME. DESPITE MULTIPLE ATTEMPTS, IT WAS NOT POSSIBLE TO ADVANCE THE CATHETER, SO THE ORDERING OF THE PROCEDURE REQUESTS ANOTHER ELEMENT OF THE SAME BRAND AND REFERENCE, NOTING THAT IT WORKS CORRECTLY AND DID NOT PRESENT COMPLICATIONS. FOR THIS REASON, THE CUSTOMER REQUESTED TO REVIEW THE ITEM UNDER WARRANTY CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986305 ↗
• MalfunctionDec 12, 2022Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE QUALITY DEPARTMENT REPORTED FAILURE OF URETERAL STENT DURING THE LEFT ENDOSCOPIC URETEROLITHOTOMY PROCEDURE. WHEN ENTERING THE DOUBLE J CATHETER AND POSITIONING IT ON THE GUIDE, IT WAS EVIDENT THAT IT COULD NOT BE ADVANCED DESPITE HAVING THE EQUIPMENT AND THE GUIDE IN THE PROPER POSITION. IT WAS OBSERVED THAT THE DISTAL END FOLDS BACK ON ITSELF IN THE FORM OF AN ACCORDION. WHEN EXTRACTING THE CATHETER, IT SHOWS DETERIORATION AND ANGULATION OF THE SAME. DESPITE MULTIPLE ATTEMPTS, IT WAS NOT POSSIBLE TO ADVANCE THE CATHETER, SO THE ORDERING OF THE PROCEDURE REQUESTS ANOTHER ELEMENT OF THE SAME BRAND AND REFERENCE, NOTING THAT IT WORKS CORRECTLY AND DID NOT PRESENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958668 ↗
• MalfunctionOct 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE URETERAL STENT WAS FOUND BROKEN AT THE LOOP AND THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT. THE CUSTOMER OPENED ANOTHER PACKAGE FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650753 ↗
• MalfunctionSep 7, 2022Material Fragmentation; Device Handling Problem; Material Fragmentation; Device Handling Problem

  IT WAS REPORTED THAT URETERAL STENT WAS FRACTIONATED WHILE OPENING THE PACKAGE AND PREVENTED THE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370231 ↗
• MalfunctionNov 29, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE URETERAL STENT TIP DID NOT HAVE A GRADUAL NARROWING, BOTH THE TIP DIAMETERS ARE SIMILAR. WHEN THE USER TRIED TO IDENTIFY THE TIP FOR STENT INSERTION, IT WAS NOTICED THAT BOTH ENDS HAVE A SIMILAR OPENING DIAMETER.

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

  MAUDE report 12882739 ↗
• MalfunctionJun 4, 2019Break

  IT WAS REPORTED THAT AT THE MOMENT OF OPENING THE PACKAGE IT WAS DETECTED THAT A PART OF THE URETERAL STENT WAS FRAGMENTED. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC VIA EMAIL ON (B)(6) 2019; CUSTOMER SAYS THE BRAKE WAS IN THE DISTAL END OF THE STENT.

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

  MAUDE report 8669281 ↗
• InjuryOct 4, 2018Break

  IT WAS REPORTED THAT AFTER A RENAL TRANSPLANT PROCEDURE THE DOCTOR WENT TO REMOVE THE DOUBLE-JACKAL STENT/CATHETER FROM THE PATIENT. UPON REMOVAL IT WAS CLEAR THAT THE STENT/CATHETER HAD BROKEN, LEAVING A 3CM PIECE OF STENT/CATHETER IN THE PARENCHYMAL TISSUE. PER ADDITIONAL INFORMATION RECEIVED FROM IBC VIA EMAIL ON 27SEP2018; THE STENT/CATHETER WAS BROKEN INSIDE OF THE PATIENT AND IT WAS DECIDED TO LEAVE THE SEGMENT IN PLACE. THE PATIENT WAS GIVEN THE ANTIBIOTIC, CARBAPENEMIC. IT WAS UNKNOWN IF OR WHEN THE PIECE WOULD BE REMOVED.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 7933513 ↗
• MalfunctionJul 24, 2018Break; Material Frayed; Break

  IT WAS REPORTED THAT AS THE OPTIMA INLAY WAS BEING PASSED THROUGH THE GUIDE, THE CATHETER FRACTURED ON THE DISTAL TIP, AND IT WAS IMPOSSIBLE TO PASS, ANOTHER CATHETER WAS USED.

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

  MAUDE report 7713628 ↗