Advanix Pancreatic Stent KitRecalls & reported problems across all models
Boston Scientific Corporation · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 13 models of Advanix Pancreatic Stent Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Jan 6, 2017 and Jul 22, 2025 — classified as 6 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (15 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
Reports received per month, all models
Most reported Advanix Pancreatic Stent Kit problems
Device problems
- Material Deformation15
- Entrapment of Device6
- Device Packaging Compromised4
- Problem with Sterilization4
- Use of Device Problem3
- Adverse Event Without Identified Device or Use Problem2
- Kinked2
- Migration or Expulsion of Device2
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions10
- Perforation4
- Inflammation2
- No Known Impact Or Consequence To Patient2
- Pain2
- Abdominal Pain1
- Thrombosis/Thrombus1
Advanix Pancreatic Stent Kit models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advanix™ Pancreatic Stent Kit M00537560CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Pancreatic Stent Kit M00537390CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Pancreatic Stent Kit M00537410CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Pancreatic Stent Kit M00537510CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Pancreatic Stent Kit M00537500CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent Kit M00537520CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent Kit M00537360CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent Kit M00537460CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent Kit M00537470CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent Kit M00537540CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent Kit M00537350CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent Kit M00537380CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent Kit M00537400CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Advanix Pancreatic Stent Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Migration; Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS IMPLANTED IN THE PANCREATIC DUCT TO PREVENT PANCREATITIS DUE TO SPONTANEOUS DROP DURING AN ENDOSCOPIC PANCREATIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING A ROUTINE FOLLOW UP CHECK-UP, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND REVEALED THAT THE STENT REMAINED WITHIN THE INTESTINAL TRACT AND APPEARED TO HAVE PENETRATED IT. THE STENT WAS LEFT IN PLACE, AND A GASTROSCOPY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025. THE PROCEDURE CONFIRMED THAT THE STUMP OF THE PANCREATIC DUCT STENT HAD ENTERED THE DIVERTICULUM AND WAS SUCCESSFULLY REMOVED WITHOUT ANY SIGNS OF PERFORATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22572173 ↗MalfunctionJun 23, 2025Entrapment of Device; Material Deformation; Material Integrity Problem; Entrapment of Device; Material Deformation; Material Integrity Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT A SUSPECTED PANCREATIC CANCER DURING AN ENDOSCOPIC PANCREATIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE HOLE IN THE ACCESSORY PUSHER WAS TOO SMALL, WHICH PREVENTED THE GUIDEWIRE FROM EXITING AS INTENDED. THERE MAY BE TRACES OF THE EXIT BEING FORCIBLY WIDENED BY THE NURSE WHERE THE PUSHER'S GUIDEWIRE COMES OUT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT WAS KINKED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22312571 ↗MalfunctionApr 25, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE LUMEN OF THE STENT COLLAPSED. ANOTHER ADVANIX PANCREATIC STENT WAS USED 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 21914633 ↗MalfunctionMar 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS IMPLANTED TO TREAT A PANCREATITIS IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED THROUGH THE ENDOSCOPE FORCEPS CHANNEL OVER A GUIDE WIRE. UNDER ENDOSCOPIC MONITORING, A KINK (DENT) WAS OBSERVED IN THE STENT THAT EMERGED FROM THE ENDOSCOPE TIP, AND ITS USE WAS DISCONTINUED. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646879 ↗MalfunctionNov 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PIGTAIL STENT DID NOT CURL AS USUAL. ANOTHER OF THE SAME DEVICE WAS USED 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 20784973 ↗MalfunctionSep 30, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED IN THE PANCREATIC DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO CROSS THE GUIDEWIRE THROUGH THE STENT. THE GUIDEWIRE GOT STUCK IN THE MIDDLE OF THE STENT LOOP. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT LOOP WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334222 ↗MalfunctionJan 12, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE PANCREA DRAINAGE PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT DID NOT ROLL UP CAUSING IT TO SLIP. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE PANCREATIC STENT WAS KINKED; THEREFORE, THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16153434 ↗InjuryNov 3, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED, AN ADVANIX RX PANCREATIC STENT WAS USED FOR PANCREATITIS PREVENTION. THE EVENT DATE WAS NOT REPORTED. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND AN EMERGENCY ERP WAS PERFORMED. THE ADVANIX RX PANCREATIC STENT PENETRATED INTO THE PANCREATIC DUCT, AND UP TO THE PANCREATIC PARENCHYMA. THE STENT WAS REMOVED IMMEDIATELY, A NEW STENT WAS PLACED, AND PANCREATIC DUCT DRAINAGE WAS PERFORMED. PORTAL VEIN THROMBOSIS WAS OBSERVED, AND DIRECT ORAL ANTICOAGULANT (DOAC) WAS ADMINISTERED FOR ABOUT A MONTH. THE PATIENT RECOVERED AND WAS DISCHARGED AFTER A MONTH AND A HALF.
Patient problems: Abdominal Pain; Perforation; Thrombosis/Thrombus
MAUDE report 15723073 ↗MalfunctionMar 24, 2022Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE IN THE PANCREAS, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN OPENED THAT PACKAGE, IT WAS NOTED THAT THE STENT HAD A SLIGHT BENT. WHEN THE PHYSICIAN INSERTED THE PUSHER, IT COULD NOT BE INSERTED EASILY AND WHEN IT WAS REMOVED FROM THE PATIENT, THE BENT BECAME MORE NOTICEABLE. ANOTHER ADVANIX PANCREATIC STENT OF A DIFFERENT SIZE 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 13894808 ↗InjuryNov 9, 2021Difficult or Delayed Positioning; Use of Device Problem; Difficult or Delayed Positioning; Use of Device Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ADVANCED THE STENT THROUGH THE GUIDEWIRE AND WHEN IT WAS PULLED OUT FIRMLY AND FORCEFULLY, THE GUIDEWIRE MAY HAVE BOUNCE BACK AND PERFORATED AND THE PANCREATIC DUCT STENT WAS ALSO ADVANCED THROUGH THE GUIDE WIRE AND BECAME PERFORATED. A PERFORATION OF THE PANCREATIC DUCT OCCURRED WHILE THE DEVICE WAS IN PLACE. THE PROCEDURE WAS COMPLETED IN AN EMERGENCY SURGERY TO TREAT THE PERFORATION AND A PANCREATICODUODENECTOMY WAS PERFORMED. AFTER THAT PROCEDURE THE PATIENT CONDITION WAS STABLE AND THE PATIENT WAS DISCHARGED.
Patient problems: Perforation
MAUDE report 12776824 ↗MalfunctionJul 22, 2021Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STENT WAS TRIED TO INSERT INTO THE SCOPE CHANNEL OF THE ENDOSCOPE, IT WAS NOTED THAT THE STENT WAS SLIGHTLY KINKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DIFFERENT DEVICE MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS "NO PATIENT INJURY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12210858 ↗MalfunctionApr 8, 2021Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PERFORMED ON (B)(6) 2021. DURING UNPACKING, OUTSIDE THE PATIENT, THE STENT WAS FOUND TO BE BENT. THEREFORE, THE USAGE WAS DISCONTINUED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11636057 ↗MalfunctionOct 26, 2020Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT KIT WAS OPENED TO BE USED FOR PANCREATIC DUCT STENT INSERTION. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING PREPARATION,, WHEN UNPACKING THE DEVICE, IT WAS FOUND THAT THE STENT BODY WAS CRUSHED. THE PROCEDURE WAS SUCCESSFULLY 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 10733195 ↗MalfunctionJul 15, 2020Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS GOING TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS PROTRUDING FROM THE PLASTIC CASE AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 10278180 ↗MalfunctionJun 18, 2020Material Deformation; Material Deformation
IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILE DUCT AND PANCREATIC DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE,THE GUIDEWIRE COULD NOT BE INSERTED INTO THE STENT. THE PHYSICIAN NOTICED THAT THE STENT APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT MODEL. 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 10168662 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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