NavigatorRecalls & reported problems across all models

We found 4 models of Navigator by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Sep 21, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Navigator problems

Navigator models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Navigator M0062502040

  CATHETER, UROLOGICAL
  11 reports
• Navigator M0062502020

  CATHETER, UROLOGICAL
  10 reports
• Navigator M0062502030

  CATHETER, UROLOGICAL
  5 reports
• Navigator M0062502010

  CATHETER, UROLOGICAL
  1 report

Recent Navigator adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Peeled/Delaminated; Material Deformation

  It was reported that a Navigator Access Sheath device was set to be used during a Lithotripsy procedure. Reportedly, upon opening it was found that the sheath crumbled and began to chip before use. Additionally, the sheath was also noticed to be kinked. The procedure was completed with another of the same device with no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842276 ↗
• MalfunctionAug 27, 2026Material Fragmentation

  Sheath crumbled and began to chip before the item was ever used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482721 ↗
• InjuryDec 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USE DURING A PROCEDURE. DURING STONE LASER TREATMENT IN THE KIDNEY'S UPPER POLE, THEY NOTICED BLUE FLECKS IN THE PATIENT'S BLADDER. REPORTEDLY, IT WAS FOUND THAT THE NAVIGATOR BREAKS APART AND THE PHYSICIAN RE-ENTERED THE URETER SIX TIMES TO ENSURE ALL PLASTIC PIECES WERE RETRIEVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838091 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE. PRIOR TO PROCEDURE, THE PHYSICIAN PLACES THE ACCESS SHEATH OVER THE WIRE AND NOTICED THAT THE CONNECTION OF THE SHEATH TO THE HUB WAS FRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556751 ↗
• MalfunctionApr 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE URETHRAL SHEATH RUPTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075919 ↗
• MalfunctionFeb 27, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED IN THE URINARY TRACT DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE COATING INSIDE THE SHEATH PEELED OFF AND A HAIR-LIKE SEMI-TRANSLUCENT THREAD WAS NOTICED WHEN THE SCOPE WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443340 ↗
• MalfunctionJan 9, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE RIGHT URETER DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE COATING ON THE INNER LAYER OF THE SHEATH WAS PEELED OFF LIKE SILK THREADS AND BLOCKED THE FRONT VIEW OF THE LITHOVUE. 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 16126022 ↗
• MalfunctionNov 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SHEATH WAS BENT, EXPOSING THE WIRE INSIDE. THE PROCEDURE WAS COMPLETED WITH SAME ORIGINAL NAVIGATOR ACCESS SHEATH. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814231 ↗
• MalfunctionOct 20, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATION ACCESS SHEATH DEVICE WAS USED DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE INNER LINING OF THE ACCESS SHEATH WAS PEELING BACK AFTER A STONE BASKETED IN A 1.9F ZERO TIP WAS PULLED THROUGH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639623 ↗
• MalfunctionOct 20, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE ACCESS SHEATH WAS INSERTED; HOWEVER, THE SCOPE HAD MINIMAL VISIBILITY THROUGH THE SHEATH BECAUSE OF MULTIPLE FIBERS HANGING INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF ONE NAVIGATOR, SHOWING THE PEELED INNER COATING OF THE SHEATH, WAS SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639494 ↗
• MalfunctionNov 7, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE INTERNAL LINING OF THE SHEATH WAS PEELING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF 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 12759229 ↗
• MalfunctionNov 2, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AN INTERNAL DESQUAMATION WAS NOTED ON THE DEVICE. 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 12736525 ↗
• InjurySep 24, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE BLADDER DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE FLEXIBLE URETEROSCOPE AND SHEATH WERE REMOVED IT WAS NOTICED THAT THERE WERE PLASTIC COATING FROM MULTIPLE AREAS OF THE SHEATH THAT DISINTEGRATED. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF DAMAGE TO ANY OTHER DEVICES USED IN THE PROCEDURE. THE CYSTOSCOPE WAS RE-INTRODUCED INTO THE BLADDER AND MULTIPLE FRAGMENTS WERE IRRIGATED OUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 28, 2021. IT WAS REPORTED THAT CYSTOURETHROSCOPY, LASER LITHOTRIPSY PROCEDURE WAS PERFORMED AND WAS COMPLETED WITH THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525433 ↗
• MalfunctionSep 3, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE BLADDER DURING A CYSTOURETHEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PLASTIC COATING CHIPPED OFF THE BLADDER. IT WAS REPORTED THAT THE CHIPPED PLASTIC COATING WAS IRRIGATED OUT OF THE BLADDER. THE PROCEDURE WAS COMPLETED WITH THIS 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 12420793 ↗
• MalfunctionFeb 5, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER LINING OF THE SHEATH PEELED OFF AND WAS PUSHED OUT OF THE END OF THE SHEATH WHEN A SCOPE WAS PASSED THROUGH THE DEVICE. THE PROCEDURE WAS COMPLETED AT THIS TIME. REPORTEDLY, NO PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11288910 ↗

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