Navigator HD M0062502210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729839064), received between Jul 10, 2019 and Aug 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USED DURING A PROCEDURE. DURING PREPARATION, IT WAS NOTICE THAT THE COATING INSIDE THE SHEATH GOT 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 22868676 ↗
• MalfunctionApr 3, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE KIDNEY DURING A UTEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SHEATH WAS STIFF AND IT WAS ALSO NOTED THAT THE DISTAL PART OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665546 ↗
• MalfunctionOct 20, 2022Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE COATING SEEMS TO BE PEELING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME NAVIGATOR HD ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT OUTCOME FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDINGS OF INNER COATING OF SHEATH WAS PEELED. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. NOTE: A PHOTO SHOWING ONE NAVIGATOR HD ACCESS SHEATH WAS SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639189 ↗
• MalfunctionJan 6, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT A PIECE OF THE SHEATH BROKE OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT. 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 13177947 ↗
• MalfunctionAug 28, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URETER DURING A UTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE OUTER LUMEN OF THE ACCESS SHEATH BROKE IN HALF WHEN COATED WITH WATER. 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 8939969 ↗
• MalfunctionJul 10, 2019Peeled/Delaminated; Peeled/Delaminated

  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) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A CLEAR STUFF WAS NOTICED IN THE URETER OF THE PATIENT WHICH WAS CONFIRMED TO BE THE INNER FILM OF THE SHEATH THAT HAVE PEELED OFF. A PHOTO SENT BY THE CUSTOMER HAS CONFIRMED THAT INNER FILM OF THE SHEATH WAS PEELING OFF. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775364 ↗