Navigator HD M0062502260Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729837558), received between Feb 14, 2018 and Sep 22, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS TO BE USE ON A PROCEDURE; HOWEVER, IT WAS NOTICED THAT THE TAPE INSIDE OF THE CARDBOARD BOX IS NOT PROPERLY ATTACHED AND STUCK TO THE PRODUCT. REPORTEDLY, THE SIDE OF THE BOX WAS TORN. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23115970 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A FLEXIBLE URETEROSCOPY PROCEDURE USING A NAVIGATOR ACCESS SHEATH DEVICE, A URETHRAL PERFORATION OCCURRED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 19277344 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A TRANSURETHRAL STONE REMOVAL. DURING WITHDRAWAL OF THE SHEATH, A DAMAGE FATTY TISSUE WAS FOUND IN THE URETER. HOWEVER, THE EVENT WAS NOT CAUSED BY THE DEVICE, BUT IT WAS IATROGENIC RESULTING FROM MEDICAL INTERVENTION. REPORTEDLY, IT WAS A TORTUOUS URETER, AND THERE WAS CONSIDERABLE RESISTANCE DURING INSERTION OF ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. A URETERAL STENT WAS PLACED, AND THE PATIENT WAS MONITORED. THE PATIENT CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19252139 ↗
• MalfunctionApr 29, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS TO BE USED DURING A URETEROSCOPY PROCEDURE. IT WAS FOUND THAT THE PACKAGE HAD A HOLE IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210281 ↗
• MalfunctionOct 24, 2023Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO NAVIGATOR ACCESS SHEATH THAT WERE UNPACKED PRIOR TO PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NAVIGATOR ACCESS SHEATH DEVICES WERE ABOUT TO BE USED PRIOR TO PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THAT THE BOX IN WHICH THE ITEMS WERE SHIPPED HAS BEEN WET AND DAMAGED DURING TRANSIT. IT APPEARS THAT THE CONTENTS OF THE BOX HAVE ALSO BEEN AFFECTED. SAME ISSUE OCCURRED WITH THE SECOND NAVIGATOR ACCESS SHEATH DEVICE. ADDITIONALLY, THIS WERE NOT USED IN A PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994697 ↗
• MalfunctionOct 24, 2023Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO NAVIGATOR ACCESS SHEATH THAT WERE UNPACKED PRIOR TO PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NAVIGATOR ACCESS SHEATH DEVICES WERE ABOUT TO BE USED PRIOR TO PROCEDURE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THAT THE BOX IN WHICH THE ITEMS WERE SHIPPED HAS BEEN WET AND DAMAGED DURING TRANSIT. IT APPEARS THAT THE CONTENTS OF THE BOX HAVE ALSO BEEN AFFECTED. SAME ISSUE OCCURRED WITH THE SECOND NAVIGATOR ACCESS SHEATH DEVICE. ADDITIONALLY, THIS WERE NOT USED IN A PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994618 ↗
• InjuryMay 3, 2023Adverse 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 ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SHEATH PERFORATED THE URETER OF THE PATIENT WHEN ADVANCED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL NAVIGATOR HD ACCESS SHEATH DEVICE. A DOUBLE-J STENT HAD TO BE PLACED INTO THE PATIENT FOR THREE WEEKS. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: Perforation

  MAUDE report 16860016 ↗
• InjuryMay 3, 2023Adverse 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 ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SHEATH PERFORATED THE URETER OF THE PATIENT WHEN ADVANCED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL NAVIGATOR HD ACCESS SHEATH DEVICE. A DOUBLE-J STENT HAD TO BE PLACED INTO THE PATIENT FOR THREE WEEKS. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: Perforation

  MAUDE report 16860013 ↗
• MalfunctionApr 10, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR WAS USED DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A RESISTANCE OR SCRAPING WAS FELT AGAINST THE INNER WALL OF THE OUTER SHEATH WHEN THE INNER SHEATH WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710095 ↗
• MalfunctionNov 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, THE DEVICE WAS INSPECTED, AND IT WAS NOTICED THAT THE BLACK TIP OF THE DILATOR WAS BROKEN. 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 15751332 ↗
• MalfunctionSep 3, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS UNPACKED FOR A PROCEDURE ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTED THAT THE OUTER BOX OF THE PRODUCT WAS DAMAGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420800 ↗
• MalfunctionJun 17, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE KIDNEY DURING A LITHOTRIPSY PROCEDURE PERFORMED ON MAY 26, 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TUBE IN THE SHEATH WAS PEELED OFF. REPORTEDLY, NO PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020578 ↗
• MalfunctionOct 22, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE URETER DURING A TRANSURETHRAL STONE CRUSHING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT ONE-FIFTH OF THE SHEATH TIP APPEARED TO BE MISSING. ALSO, THE TIP WAS NOT IN A CIRCULAR SHAPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717328 ↗
• MalfunctionFeb 14, 2018Torn Material; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE URETER DURING AN URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER SHEATH DISLODGED AND CAME OUT. IT WAS REPORTED THAT NO PART OF THE SHEATH DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR 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 Consequences Or Impact To Patient

  MAUDE report 7271352 ↗