NaviFlex RX Delivery SystemRecalls & reported problems across all models

We found 4 models of NaviFlex RX Delivery System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 168 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2017 and Sep 30, 2026 — classified as 76 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Break” (158 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 NaviFlex RX Delivery System problems

NaviFlex RX Delivery System models

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

• NaviFlex™ RX Delivery System M00533560

  CATHETER, BILIARY, DIAGNOSTIC
  112 reports
• NaviFlex™ RX Delivery System M00533580

  CATHETER, BILIARY, DIAGNOSTIC
  39 reports
• NaviFlex™ RX Delivery System M00535060

  CATHETER, BILIARY, DIAGNOSTIC
  12 reports
• NaviFlex™ RX Delivery System M00533570

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports

Recent NaviFlex RX Delivery System adverse event reports

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

• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955152 ↗
• InjurySep 23, 2026Break

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50873860 ↗
• MalfunctionSep 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599645 ↗
• 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 ↗
• MalfunctionJul 28, 2026Break; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057608 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841660 ↗
• 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 ↗
• MalfunctionMay 22, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE END CAP OF THE DELIVERY SYSTEM BROKE UPON DEPLOYMENT OF THE STENT. THE STENT WAS DEPLOYED AS INTENDED; HOWEVER, THE DELIVERY SYSTEM FRACTURED DURING DEPLOYMENT. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH 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 25260042 ↗
• InjuryFeb 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE WHILE THE STENT WAS BEING DEPLOYED, RESULTING IN A PORTION OF THE DEVICE REMAINING INSIDE THE PATIENT. THE BROKEN GUIDE CATHETER WAS REMOVED USING RAT TOOTH FORCEPS. ANOTHER NAVIFLEX DELIVERY SYSTEM WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309799 ↗
• MalfunctionJan 26, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE HEPATIC DUCT FOR A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 10FR X 10CM DOUBLE PIGTAIL STENT WAS PROPERLY LOADED ONTO THE ADVANIX 10FR DELIVERY SYSTEM AND POSITIONED OVER THE GUIDEWIRE. UPON DEPLOYMENT, THE RADIOPAQUE MARKER ON THE INNER CATHETER OF THE DELIVERY SYSTEM REMAINED WITHIN THE HEPATIC DUCT EVEN AFTER THE GREEN DEPLOYMENT INDICATOR ON THE HANDLE WAS ACTIVATED. THE DISTAL END OF THE INNER CATHETER WAS STILL IN PLACE AND SO THEY NEEDED TO REMOVE THE ENTIRE SYSTEM AND ATTEMPT THE STENT PLACEMENT AGAIN. THEY THEN DECIDED TO PROCEED WITH A DUODENAL BEND "STRAIGHT" STENT INSTEAD OF A DOUBLE PIGTAIL STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183506 ↗
• InjuryJan 9, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE METALLIC STYLET OF THE NAVIFLEX DELIVERY SYSTEM BROKE AFTER STENT PLACEMENT. THE DELIVERY SYSTEM WAS REMOVED, AND THE ORIGINAL STENT REMAINS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025612 ↗
• 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 ↗
• InjuryOct 29, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX RX DELIVERY SYSTEM WAS USED TO IMPLANT A PLASTIC STENT TO TREAT A BILIARY OBSTRUCTION CAUSED BY STONES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INTRODUCER FAILED TO FULLY WITHDRAW AND BECAME STUCK IN THE STENT. IT THEN DETACHED FROM THE PULL WIRE SYSTEM, LEAVING THE BLACK INTRODUCER COMPONENT INSIDE THE STENT AND IT WAS REMOVED USING FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414495 ↗
• MalfunctionOct 23, 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 NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) WITH STENT IMPLANT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE INNER SHEATH OF THE DEVICE WAS SEPARATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367090 ↗

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