Navigator HDRecalls & reported problems across all models

We found 8 models of Navigator HD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2017 and Sep 22, 2026 — classified as 1 death, 15 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (29 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 HD problems

Navigator HD models

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

• Navigator HD M0062502220

  endoscopic access overtube, gastroenterology-urology
  1 death31 reports
• Navigator HD M0062502230

  endoscopic access overtube, gastroenterology-urology
  29 reports
• Navigator HD M0062502260

  endoscopic access overtube, gastroenterology-urology
  14 reports
• Navigator HD M0062502250

  endoscopic access overtube, gastroenterology-urology
  13 reports
• Navigator HD M0062502210

  endoscopic access overtube, gastroenterology-urology
  6 reports
• Navigator HD M0062502280

  endoscopic access overtube, gastroenterology-urology
  5 reports
• Navigator HD M0062502240

  endoscopic access overtube, gastroenterology-urology
  2 reports
• Navigator HD M0062502290

  endoscopic access overtube, gastroenterology-urology
  1 report

Recent Navigator HD adverse event reports

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

• MalfunctionSep 22, 2026Nonstandard Device; Material Deformation

  It was reported that a Navigator was used during a procedure. Reportedly, it was found that the tip of the dilator was damaged. The procedure was completed with another of the same device with no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852828 ↗
• MalfunctionSep 14, 2026Unsealed Device Packaging

  It was reported that a Navigator Access Sheath device was set to be used during a procedure. Reportedly, it was found that the sealing label was peeled off. Additionally, there was no damage to the outer box. There was no patient or procedure involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754795 ↗
• MalfunctionAug 12, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a Navigator Access Sheath device was set to be used in a procedure. Reportedly, an eyelash hair was found in the package. There was no patient or procedure involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223055 ↗
• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS SET TO BE USED DURING A URETEROSCOPY INTERVENTION PROCEDURE. DURING PREPARATION, UPON OPENING THE PACKAGE, THEY NOTICED THAT THE COATING ON THE TIP OF THE SHEATH WAS PARTIALLY 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 23873092 ↗
• 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 ↗
• MalfunctionSep 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING PREPARATION, THEY NOTICED A SCRATCH AT THE END OF THE OUTER SHEATH'S DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069820 ↗
• 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 ↗
• DeathJun 17, 2025Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, THE NAVIGATOR ACCESS SHEATH "BROKE APART WHILE INSIDE THE PATIENT." REPORTEDLY, THE FRAGMENTS WERE REMOVED USING A GRASPER. NINE DAYS LATER, THE PATIENT "CALLED 911 COMPLAINING OF SEVERE ABDOMINAL PAIN, NAUSEA, INCLUDING ABDOMINAL DISTENSION AND FEELINGS OF CONSTIPATION." REPORTEDLY, THESE FEELINGS HAD BEEN "PRESENT SINCE HER DISCHARGE" FOLLOWING THE URETEROSCOPY PROCEDURE. UPON ARRIVAL AT THE EMERGENCY ROOM, IT WAS NOTED THE PATIENT WAS EXPERIENCING HYPOTENSION AND ATRIAL FIBRILLATION. OVER THE NEXT FIVE DAYS THE PATIENT'S "ABDOMINAL COMPLICATIONS WORSENED RAPIDLY." IT WAS NOTED THAT THE PATIENT WAS HAVING "PERITONITIS AND LIKELY AN ISCHEMIC OR INFECTIOUS BOWEL." IT WAS ALSO NOTED THAT THE URINE INPUT WAS SEVERELY LIMITED AND WAS ULTIMATELY DIAGNOSED WITH SEPSIS, SEPTIC SHOCK, AND LACTIC ACIDOSIS. AFTER SEVERAL DAYS, THE PATIENT WAS "UNRESPONSIVE IN HER HOSPITAL BED AND PRONOUNCED DEAD." IT WAS FURTHER REPORTED THAT AN AUTOPSY NOTED "HYPERTENSIVE AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND "COMPLICATIONS [FROM] URETEROSCOPY." FURTHER, IT WAS REPORTED THAT "THE P

  Patient problems: Abdominal Pain; Atrial Fibrillation; Constipation; Ischemia; Low Blood Pressure/ Hypotension; Peritonitis; Sepsis; Septic Shock; Urinary Retention

  MAUDE report 22236416 ↗
• MalfunctionApr 4, 2025Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USE DURING URETERAL LITHOTRIPSY PROCEDURE. DURING UNPACKING IT WAS FOUND THAT THE URETERAL SHEATH INNER CORE WAS 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 21772956 ↗
• MalfunctionFeb 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE ACCESS SHEATH DID NOT HAVE AN OPENING IN THE END OF THE SHEATH FOR THE WIRE TO BE FED UP. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428475 ↗
• MalfunctionDec 9, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A LITHOTOMY UNDER FLEXIBLE ENDOSCOPE PROCEDURE. DURING THE PROCEDURE, THE URETERAL SHEATH WAS DAMAGED. ADDITIONALLY, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885507 ↗
• MalfunctionDec 2, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSERT A URETEROSCOPE INSIDE THE SHEATH, HOWEVER A SEVERE RESISTANCE WAS FELT INSIDE THE LUMEN OF THE SHEATH. THE PHYSICIAN SUSPECTED AN ABRASION OR PEELING OF THE COATING INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825334 ↗
• MalfunctionNov 20, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE INSIDE WAS STICKING OUT SHARPLY AND CAN BE SEEN THROUGH SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735741 ↗
• MalfunctionOct 18, 2024Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A URETEROSCOPIC LITHOTRIPSY PROCEDURE, WHEN THE NAVIGATOR ACCESS SHEATH WAS ABOUT TO BE INSERTED, IT WAS OBSERVED FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487175 ↗
• MalfunctionSep 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF A URETEROLITOTOMIA PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE OUTER SHEATH OF THE NAVIGATOR WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247376 ↗

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