NaviFlex™ RX Delivery System M00533570Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729787099), received between Nov 8, 2022 and Jun 13, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionJun 13, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER STYLET BROKE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206620 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED FOR A COMMON BILE DUCT DRAINAGE DURING A STENT POSITIONING PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INTRODUCER BROKE IN HALF. THE DEVICE WAS REMOVED FROM THE PATIENT, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168345 ↗
• InjuryNov 13, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILIARY TREE TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED AS THE GUIDE CATHETER WAS PUSHED OFF AND REMAINED INSIDE THE STENT AND WAS COMPLETELY DETACHED FROM THE DELIVERY SYSTEM INSIDE THE PATIENT. SUBSEQUENTLY, THE BROKEN GUIDE CATHETER WAS REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIFLEX DELIVERY SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674036 ↗
• MalfunctionSep 15, 2023Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, AS THE PHYSICIAN PUSHED THE DELIVERY SYSTEM DOWN THE SCOPE AND PULLED BACK THE CONTROLLER OF THE GUIDE CATHETER, THE GUIDE CATHETER DID NOT PULL BACK. THE GUIDE CATHETER HAD SEPARATED FROM THE DELIVERY SYSTEM. A NON-BOSTON SCIENTIFIC DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757342 ↗
• MalfunctionNov 8, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE INNER SHEATH WAS DETACHED/SEPARATED. ANOTHER NAVIFLEX DELIVERY SYSTEM WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15750624 ↗