NaviFlex™ RX Pusher M00535010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729856214), received between Nov 12, 2018 and Jul 15, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED TO TREAT JAUNDICE DURING A BILIARY STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS DELIVERED THROUGH A DUODENAL SCOPE WITH A WORKING CHANNEL OF 4.2MM. AFTER THE STENT WAS PUSHED INTO THE BILIARY PAPILLA, IT BECAME STUCK IN THE SCOPE AND COULD NOT BE ADVANCED FURTHER. AFTER 15 MINUTES OF ATTEMPTING TO MANEUVER THE STENT, THEY DECIDED TO PULL IT OUT. THE STENT WAS FOUND TO BE SLIGHTLY DAMAGED, POSSIBLY DUE TO THE SCOPE'S ELEVATOR MECHANISM. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511575 ↗
• InjuryAug 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL PORTION OF THE STENT BECAME KINKED. IT WAS REMOVED WITH A SNARE, AND ANOTHER ADVANIX PANCREATIC STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 19, 2024, AND AUGUST 20, 2024. IT WAS REPORTED THAT IT WAS THE DISTAL PART OF THE PUSHER THAT WAS BENT, NOT THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030595 ↗
• InjuryAug 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL END OF THE STENT BECAME BENT. THE STENT WAS SUBSEQUENTLY REMOVED WITH A SNARE, AND ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 20, 2024. IT WAS REPORTED THAT IT WAS THE DISTAL PART OF THE PUSHER THAT WAS BENT, NOT THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012507 ↗
• MalfunctionJun 11, 2024Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02681, 3005099803-2024-02682, AND 3005099803-2024-02683 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER WAS TO BE USED TO TREAT A STRICTURE IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PREPARATION, THE GUIDEWIRE WAS UNABLE TO ADVANCE THROUGH THE PUSHER. THEY ATTEMPTED TO USE THREE DIFFERENT PUSHERS, BUT ALL OF THEM WERE BLOCKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512926 ↗
• MalfunctionJun 11, 2024Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02681, 3005099803-2024-02682, AND 3005099803-2024-02683 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER WAS TO BE USED TO TREAT A STRICTURE IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PREPARATION, THE GUIDEWIRE WAS UNABLE TO ADVANCE THROUGH THE PUSHER. THEY ATTEMPTED TO USE THREE DIFFERENT PUSHERS, BUT ALL OF THEM WERE BLOCKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512924 ↗
• MalfunctionJun 11, 2024Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02681, 3005099803-2024-02682 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER WAS TO BE USED TO TREAT A STRICTURE IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PREPARATION, THE GUIDEWIRE WAS UNABLE TO ADVANCE THROUGH THE PUSHER. THEY ATTEMPTED TO USE THREE DIFFERENT PUSHERS, BUT ALL OF THEM WERE BLOCKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512923 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED IN THE DORSAL PANCREATIC DUCT TO TREAT A SUSPECTED ACUTE RECURRENT PANCREATITIS WITH PANCREAS DIVISUM, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2024, THE PATIENT EXPERIENCED POST-ERCP PANCREATITIS. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AND WAS GIVEN INTRAVENOUS (IV) FLUIDS AND MEDICATION FOR PAIN MANAGEMENT. THE STENT REMAINS IMPLANTED. IN THE PHYSICIAN'S ASSESSMENT, IT IS UNKNOWN IF THERE WAS A RELATIONSHIP BETWEEN THE PATIENT'S PANCREATITIS, THE STENT AND/OR THE PROCEDURE.

  Patient problems: Pancreatitis

  MAUDE report 19490604 ↗
• MalfunctionMay 6, 2024Break; Entrapment of Device; Use of Device Problem; Break; Entrapment of Device; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER ADVANIX PANCREATIC STENT WAS USED TO TREAT PANCREATIC DUCT STENOSIS DURING AN ENDOSCOPIC BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE BECAME STUCK WHEN CROSSING THROUGH THE PUSHER. SUBSEQUENTLY, IT WAS NOTED THAT THE BACK END OF THE GUIDEWIRE WAS SLIGHTLY FLATTENED, AND THE PROXIMAL SIDE OF THE GUIDE CATHETER WAS SMASHED. THE FLATTENED PART WAS THEN CUT OFF WITH SURGICAL PLIERS AND ANOTHER ATTEMPT WAS MADE TO CROSS THE GUIDEWIRE; HOWEVER, THE SAME EVENT OF THE GUIDEWIRE BEING STUCK OCCURRED. CONSEQUENTLY, A NEEDLE WAS USED TO POKE THE INSERTION PORT OF THE PUSHER'S GUIDEWIRE LUMEN AND THE GUIDEWIRE WAS ABLE TO ADVANCE SMOOTHLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. UPDATE BASED ON A REVIEW OF COMPLAINT DETAILS ON SEPTEMBER 04, 2024. UPON FURTHER REVIEW OF THE COMPLAINT DETAILS, IT WAS INITIALLY REPORTED THAT THE PROXIMAL SIDE OF THE GUIDE CATHETER WAS SMASHED; HOWEVER, THE COMPLAINT DEVICE IS A NAVIFLEX RX PUSHER ADVANIX PANCREATIC STENT AND A GUIDE CATHETER IS NOT A COMPONENT FOR THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255106 ↗
• MalfunctionMay 3, 2024Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02071 AND 3005099803-2024-02072 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO KEEP THE DUCT OPEN FOR DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02071) WAS ATTEMPTED TO BE USED; HOWEVER, THERE WAS DIFFICULTY ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE THROUGH THE EXIT PORT. ANOTHER ADVANIX PANCREATIC STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE USED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240270 ↗
• MalfunctionMay 3, 2024Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02071 AND 3005099803-2024-02072 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO KEEP THE DUCT OPEN FOR DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE USED; HOWEVER, THERE WAS DIFFICULTY ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE THROUGH THE EXIT PORT. ANOTHER ADVANIX PANCREATIC STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02072) WAS ATTEMPTED TO BE USED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240201 ↗
• MalfunctionJan 10, 2023Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE INNER POUCH WAS OPENED AND HAD A HOLE. THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. ANOTHER NAVIFLEX PUSHER 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 16132440 ↗
• MalfunctionFeb 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT KIT WAS USED DURING A PANCREATIC STENT PLACEMENT IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, WHEN THE PHYSICIAN PASSED THE STENT THROUGH THE PUSHER, IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670717 ↗
• MalfunctionNov 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PUSHER WAS TO BE USED IN AN UNKNOWN PROCEDURE IN THE PANCREAS PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, WHEN THE NAVIFLEX RX PUSHER WAS INSERTED OVER THE GUIDEWIRE, RESISTANCE WAS MET AT THE AREA WHERE THE GUIDEWIRE CAME OUT FROM THE NAVIFLEX RX PUSHER. WHEN THE DEVICE WAS PUSHED, A COTTON-LIKE OBJECT AT THE TAIL SIDE OF THE GUIDEWIRE CAME OUT FROM THE LUMEN OF THE PUSHER. THE SOURCE OF THE OBJECT WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060485 ↗