Navigator M0062502030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729751502), received between Nov 22, 2017 and Sep 21, 2026 — 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.

• 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 ↗
• MalfunctionNov 22, 2017Torn Material; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE KIDNEY DURING A URETEROSCOPY AND LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER LINING OF THE DEVICE STARTED TO PEEL OFF/SHEARED EXPOSING THE METAL COIL. IT WAS ALSO REPORTED THAT NO PARTS DETACHED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052236 ↗