Navigator HD M0062502250Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729837992), received between Jun 5, 2018 and Dec 22, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS SET TO BE USED DURING A URETEROSCOPY INTERVENTION PROCEDURE. DURING PREPARATION, UPON OPENING THE PACKAGE, THEY NOTICED THAT THE COATING ON THE TIP OF THE SHEATH WAS PARTIALLY PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873092 ↗
• MalfunctionFeb 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE ACCESS SHEATH DID NOT HAVE AN OPENING IN THE END OF THE SHEATH FOR THE WIRE TO BE FED UP. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428475 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN INCIDENT INVOLVING THE NAVIGATOR HD THROUGH AN ARTICLE TITLED "DOES PREOPERATIVE SILODOSIN ADMINISTRATION FACILITATE URETERAL DILATATION DURING FLEXIBLE URETERORENOSCOPY? A RANDOMIZED CLINICAL TRIAL" BY TAMER DIAB, ET AL. THE ARTICLE AIMS TO ASSESS WHETHER PREOPERATIVE ADMINISTRATION OF SILODOSIN CAN FACILITATE THE PLACEMENT OF URETERAL ACCESS SHEATH (UAS) PRIOR TO FLEXIBLE URETEROSCOPY (F-URS) AND REDUCE THE OCCURRENCE OF URETERIC INJURY IN CHALLENGING CASES. THIS PROSPECTIVE RANDOMIZED CLINICAL TRIAL WAS CARRIED OUT ON 147 PATIENTS DIAGNOSED WITH UPPER URETERIC STONE OR STONE KIDNEY, NON-STENTED. THE PATIENTS WERE RANDOMLY DIVIDED INTO TWO EQUAL GROUPS. GROUP A (SILODOSIN GROUP) INCLUDED PATIENTS IN WHOM F-URS WAS DONE WITH A DAILY PREOPERATIVE INTAKE OF 8 MG SILODOSIN FOR 1 WEEK AND GROUP B (PLACEBO/CONTROL GROUP) INCLUDED PATIENTS IN WHOM F-URS WAS DONE WITH THE DAILY PREOPERATIVE INTAKE OF PLACEBO TABLETS. FURTHERMORE, IN GROUP A, A TOTAL OF 23 (33.3%) EXPERIENCED URETERAL WALL INJURY FOLLOWING UAS INSERTION, WHILE IN GROUP B, THIS OCCURRED IN 40 PATIENTS (59.7%). THE STUDY FOUND THAT THERE WAS A STATISTICALLY SIGNIFICANT DIFFERENCE IN THE

  Patient problems: Hematuria; Pain; Perforation; Unspecified Tissue Injury; Urinary Retention

  MAUDE report 19542903 ↗
• MalfunctionJun 6, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT NAVIGATOR ACCESS SHEATH DEVICE WAS TO BE USED DURING A URETEROFLEXIBLE HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT THE INNER PACKAGE WAS BROKEN, AND THE STERILE BARRIER WAS BREACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480717 ↗
• MalfunctionJun 14, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE RENAL PELVIS DURING A PERCUTANEOUS URETEROLITHOTOMY PROCEDURE PERFORMED ON MAY 17, 2023. DURING THE PROCEDURE, THE SHEATH BROKE WHEN INSERTED INTO THE PATIENT. ADDITIONALLY, THE INNER DILATOR WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124483 ↗
• InjuryJul 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN USED A SEMI RIGID URETEROSCOPE IN THE ACCESS SHEATH; HOWEVER, AFTER MULTIPLE PASS, THE INNER LINING OF THE SHEATH STARTED TO UNRAVEL INTO THE PATIENT. REPORTEDLY, THE PHYSICIAN HAD TO FISH THE SHEATH OUT WITH A BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124198 ↗
• InjuryApr 14, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE RIGHT URETER DURING A CYSTOSCOPY, RIGHT URETEROSCOPY WITH LASER LITHOTRIPSY AND RIGHT URETERAL STENT EXCHANGE PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A PIECE OF THE TIP OF THE SHEATH BROKE OFF AND WAS FOUND FLOATING IN THE KIDNEY OF THE PATIENT. REPORTEDLY, THE DETACHED PIECE WAS RETRIEVED USING A DISPOSABLE STONE GRASPER. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663763 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE SHEATH WAS BROKEN INTO TWO PIECES. A PHOTO SENT BY THE CUSTOMER CONFIRMED THE SHEATH BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10950107 ↗
• InjuryApr 10, 2020Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE RIGHT URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE ACCESS SHEATH WAS DIFFICULT TO ADVANCE THROUGH THE URETER WHICH CAUSED MINOR INJURY TO THE PATIENT. IN THE PHYSICIAN ASSESSMENT, THE MINOR INJURY WAS CAUSED BY THE UNEVENESS OF THE DEVICE HYDROPHILIC COATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. REPORTEDLY, THE PATIENT WAS GIVEN MEDICATION TO TREAT THE MINOR INJURY AND WAS REQUIRED TO STAY LONGER IN THE HOSPITAL. THE PATIENT WAS UNDER OBSERVATION FOLLOWING THE TREATMENT. THE MINOR INJURY THE PATIENT EXPERIENCED IS ABRASION OF THE URETER. REPORTEDLY, THE PATIENT'S CONDITION HAS IMPROVED FOLLOWING THE TREATMENT, AND THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Injury; Tissue Damage

  MAUDE report 9947759 ↗
• MalfunctionNov 26, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS TEARING IN THE URETHRA. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9375027 ↗
• MalfunctionOct 3, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD URETERAL ACCESS SHEATH WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A TRACE OF BLOOD LIKE STAIN WAS NOTED ON THE BOX. REPORTEDLY, THERE WERE NO DAMAGES NOTED ON THE PACKAGING. ADDITIONALLY, THIS WAS NOT USED IN A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7929639 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD URETERAL ACCESS SHEATH WAS USED IN THE URETER DURING AN URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PERFORATION OCCURRED WHILE THE PHYSICIAN WAS ADVANCING THE ACCESS SHEATH OVER THE SENSOR WIRE. A PERCUTANEOUS TUBE WAS PLACED TO DRAIN THE KIDNEY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IN THE PHYSICIANS ASSESSMENT, THE PHYSICIAN FELT THAT THE NAVIGATOR WAS TOO STIFF. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE DOING WELL.

  Patient problems: Perforation

  MAUDE report 7906575 ↗
• MalfunctionJun 5, 2018Peeled/Delaminated; Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-01788 FOR THE ZERO TIP¿ STONE RETRIEVAL BASKET AND MANUFACTURER REPORT# 3005099803-2018-01661 FOR THE NAVIGATOR URETERAL ACCESS SHEATH. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR URETERAL ACCESS SHEATH WAS USED IN THE URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ZERO TIP BASKET WAS USED IN CONJUNCTION WITH A URETERAL ACCESS SHEATH TO CAPTURE AND REMOVE A STONE FROM THE URETER. AN ATTEMPT TO REMOVE THE BASKET WITH THE STONE CAPTURED THROUGH THE USE OF THE ACCESS SHEATH WAS DONE; HOWEVER, THE BASKET WITH THE CAPTURED STONE GOT STUCK IN THE ACCESS SHEATH. THE PHYSICIAN TRIED TO PULL THE BASKET OUT OF THE ACCESS SHEATH BUT THE ATTEMPT WAS NOT SUCCESSFUL. IT WAS ALSO REPORTED THAT THE STONE WAS TOO BIG. THE BASKET WITH THE CAPTURED STONE, AND THE ACCESS SHEATH WERE PULLED OUT FROM THE PATIENT ALTOGETHER. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN THEN PULLED THE BASKET WITH THE CAPTURED STONE OUT OF THE ACCESS SHEATH SUCCESSFULLY. THE ACCESS SH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568568 ↗