NaviFlex™ RX Delivery System M00535060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729856221), received between Oct 15, 2018 and Aug 14, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Break

  It was reported to Boston Scientific Corporation that a NaviFlex RX Pancreatic Delivery System was used for placement of a pancreatic duct stent to treat severe stenosis caused by chronic pancreatitis during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During the procedure, when the pancreatic duct stent was released, the inner catheter was reported to have separated midway, and the black portion of the inner catheter remained in the duodenum. Placement of the pancreatic duct stent was completed without reported difficulty. The detached inner catheter was subsequently removed using grasping forceps. The procedure was completed using the original device. No patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260571 ↗
• InjuryAug 5, 2026Break; Adverse Event Without Identified Device or Use Problem

  It was reported to Boston Scientific Corporation that a NaviFlex RX Delivery System was used to implant a stent in the pancreatic duct to treat a stenosis during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During the procedure, the tip of the guide catheter detached. The detached guide catheter tip was retrieved using forceps. No device fragments remained inside the patient's body, and the procedure was completed using the original device.There were no patient complications reported as a results of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147518 ↗
• InjuryJul 13, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS INTENDED FOR USE DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE INNER TUBE WAS DIFFICULT TO MANIPULATE DURING STENT DEPLOYMENT AND WAS SUBSEQUENTLY DAMAGED. THEY USED GRASPING FORCEPS TO REMOVE THE BROKEN GUIDE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806748 ↗
• InjuryJan 7, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX DELIVERY SYSTEM WAS TO BE USED TO IMPLANT A STENT IN THE PANCREATIC DUCT TO TREAT CHRONIC PANCREATITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (B)(6) 2025. DURING THE PROCEDURE, THE PROXIMAL TIP OF THE INNER SHEATH RETRACTED SMOOTHLY WITHOUT RESISTANCE. HOWEVER, THE DISTAL TIP OF THE STENT DID NOT MOVE UNDER FLUOROSCOPY. REPORTEDLY, DURING RELEASE THE INNER SHEATH GOT DETACHED. THEREFORE, IT WAS GRASPED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23998749 ↗
• MalfunctionAug 15, 2025Break; Retraction Problem; Adverse Event Without Identified Device or Use Problem; Break; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED TO TREAT STRICTURES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE GUIDING CATHETER BECAME LODGED IN THE STENT, PREVENTING SUCCESSFUL DEVICE DEPLOYMENT. IN ADDITION, THE SUTURE LOOP WAS NOT ABLE TO EXIT THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819818 ↗
• MalfunctionAug 11, 2025Retraction Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PANCREATIC DELIVERY SYSTEM WAS USED TO TREAT STRICTURES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER BECAME STUCK IN THE STENT AND THE SUTURE LOOP DID NOT COME OUT OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF PULL WIRE BREAK AND GUIDE CATHETER BREAK. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777128 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX PANCREATIC DELIVERY SYSTEM WAS TO BE USED IN THE PANCREATIC DUCT DURING A PANCREATIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A CRACK ON THE DELIVERY SYSTEM. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 12, 2024. IT WAS REPORTED THAT THERE WAS A CRACK ON THE PULL WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171238 ↗
• MalfunctionSep 15, 2022Break; Retraction Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Break; Retraction Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, RESISTANCE WAS SEVERE AND THE PULLWIRE WAS BENT. WHEN THE PULLWIRE WAS PULLED OUT WITH FORCE, THE HANDLE OF THE GUIDE CATHETER CAME OFF AND THE PULLWIRE WAS DISLODGED AND WAS EXPOSED. THE DELIVERY SYSTEM WAS GRASPED WITH PLIERS TO POSITION THE STENT. THE STENT WAS DEPLOYED SUCCESSFULLY AND 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 15428774 ↗
• MalfunctionAug 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THERE WAS DIFFICULTY IN RELEASING AND IT WAS NOTICED THAT THE STENT WAS BUCKLED, HOWEVER, THE ADVANIX PANCREATIC STENT WAS DEPLOYED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395884 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS OBSERVED THAT THE STENT WAS TORN/BROKEN. STENOSIS WAS NOT SIGNIFICANTLY NARROW. THE STENT WAS SUCCESSFULLY DEPLOYED AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS 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 Consequences Or Impact To Patient

  MAUDE report 10326591 ↗
• MalfunctionDec 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN A PANCREATIC DUCT STENT PLACEMENT PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, WHEN THEY ATTEMPTED TO PLACE THE 7FR 9CM ADVANIX PANCREATIC STENT FOR CHRONIC PANCREATITIS, THE STENT KINKED WHICH CAUSES THE DEPLOYMENT FAILURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE MANUFACTURER AND DIFFERENT SIZE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8143875 ↗
• MalfunctionOct 15, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A STENTING PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE PANCREATIC DUCT, IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7966560 ↗