Navigator HD M0062502280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729839088), received between Nov 30, 2017 and Oct 2, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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.

• MalfunctionOct 2, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED IN THE KIDNEY DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6), 2023. DURING PREPARATION, THE TIP OF THE DILATOR WAS DAMAGED AND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH FRACTURED. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854645 ↗
• MalfunctionAug 9, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN PACKAGING WAS UNPACKED TO PREPARE THE DEVICE, COATING WAS FOUND TO BE DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 10, 2021: IT WAS NOTED THAT THE OUTER PART OF THE SHEATH PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294520 ↗
• InjuryNov 13, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URINARY BLADDER DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE END OF THE ACCESS SHEATH FEELS ROUGH. REPORTEDLY, THE ACCESS SHEATH POSSIBLY CAUSED A LACERATION/TEAR IN THE PATIENTS URETER. THE LACERATION WAS STITCHED AND MONITORED AFTER.

  Patient problems: Perforation

  MAUDE report 8066186 ↗
• MalfunctionJun 28, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE COATING OF THE SHEATH PEELED OFF FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645650 ↗
• MalfunctionNov 30, 2017Torn Material; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE UPPER URETER DURING A URINARY TRACT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH INNER COATING FROM THE TIP WAS PEELED OFF. IT WAS REPORTED THAT NO PARTS OF THE DEVICE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. 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. INVESTIGATION RESULTS SHOWED THAT THE INNER LINER OF THE SHEATH PEELED OFF; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070388 ↗