Advanix Pancreatic StentRecalls & reported problems across all models
Boston Scientific Corporation · 48 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 153
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 48 models of Advanix Pancreatic Stent by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 153 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Sep 17, 2026 — classified as 13 injuries, 140 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (99 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 problems
Device problems
- Material Deformation99
- Break17
- Adverse Event Without Identified Device or Use Problem16
- Kinked14
- Positioning Failure14
- Use of Device Problem12
- Unsealed Device Packaging8
- Entrapment of Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Consequences Or Impact To Patient54
- No Patient Involvement5
- No Code Available3
- No Known Impact Or Consequence To Patient3
- Inflammation2
- Pancreatitis2
- Device Embedded In Tissue or Plaque1
Advanix Pancreatic Stent models
48 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advanix™ Pancreatic Stent M00536540CATHETER, BILIARY, DIAGNOSTIC12 reports
- Advanix™ Pancreatic Stent M00536890CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Pancreatic Stent M00537260CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Pancreatic Stent M00536520CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Pancreatic Stent M00536870CATHETER, BILIARY, DIAGNOSTIC7 reports
- Advanix™ Pancreatic Stent M00537300CATHETER, BILIARY, DIAGNOSTIC7 reports
- Advanix™ Pancreatic Stent M00537330CATHETER, BILIARY, DIAGNOSTIC7 reports
- Advanix™ Pancreatic Stent M00536560CATHETER, BILIARY, DIAGNOSTIC7 reports
- Advanix™ Pancreatic Stent M00537010CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Pancreatic Stent M00537290CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Pancreatic Stent M00536880CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Pancreatic Stent M00537280CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Pancreatic Stent M00536630CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Pancreatic Stent M00536910CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Pancreatic Stent M00536580CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Pancreatic Stent M00537170CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Pancreatic Stent M00537020CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Pancreatic Stent M00537240CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Pancreatic Stent M00537320CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Pancreatic Stent M00536390CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Pancreatic Stent M00537130CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00537150CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00537180CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00537340CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00536760CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00536410CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00536590CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00536710CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Pancreatic Stent M00537110CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00537120CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00537190CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00537030CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00537230CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536260CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536270CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536290CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536370CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536430CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536450CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536460CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536470CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536570CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536620CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536650CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536660CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536670CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536680CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Pancreatic Stent M00536720CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Advanix Pancreatic Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Break
It was reported to Boston Scientific Corporation that an Advanix Pancreatic stent was attempted to be implanted to treat stones during a stone removal procedure performed on August 25, 2026. During procedure, the stent broke while loading on wire. The procedure was completed using another of the same device. There are no patient complications reported as result of the procedure. There was no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805834 ↗MalfunctionSep 4, 2026Use of Device Problem; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600410 ↗MalfunctionAug 11, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211002 ↗MalfunctionAug 3, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112116 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000303 ↗MalfunctionJul 16, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841741 ↗MalfunctionMay 7, 2026Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED INTO THE BILE DUCT TO TREAT AN OBSTRUCTION CAUSED BY STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2026. PRIOR TO PROCEDURE AND UPON OPENING THE DEVICE PACKAGE, IT WAS OBSERVED THAT THERE WAS A TEAR IN THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108650 ↗MalfunctionApr 24, 2026Difficult to Advance; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN THE PANCREATIC DUCT TO TREAT A MASS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE STENOSIS, AND THE PHYSICIAN FOUND A TEAR IN THE FRONT OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 24990365 ↗MalfunctionJan 21, 2026Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE MAIN PANCREATIC DUCT TO TREAT A PANCREATIC CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THAT DEVICE RELEASE WAS ATTEMPTED AT THE INTENDED SITE, BUT THE INNER TUBE COULD NOT BE WITHDRAWN. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS KINKED AND DAMAGED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130754 ↗MalfunctionDec 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927681 ↗MalfunctionDec 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926910 ↗MalfunctionDec 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE PANCREATIC DRAINAGE (ERPD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE DISTAL PART OF THE STENT WAS BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926603 ↗MalfunctionDec 1, 2025Contamination; Contamination
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED DURING A LEADING BARB PANCREATIC DUCT STENT STRAIGHT LEADING BARB PROCEDURE PERFORMED ON UNKNOWN DATE OF PROCEDURE. IT WAS REPORTED THAT DIRT ON EXTERIOR (A STICKY RESIDUE IS PRESENT). THERE WERE NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687010 ↗MalfunctionNov 24, 2025Positioning Failure; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Use of Device Problem; Material Deformation; 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 A MALIGNANT PANCREATIC DUCT STRICTURE IN THE PANCREATIC DUCT HEAD REGION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. 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 BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU). NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638985 ↗MalfunctionNov 10, 2025Entrapment of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Deformation; 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 A PANCREATIC DUCT STONE IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE STENT COULD NOT PASS SMOOTHLY OVER THE GUIDEWIRE BECAUSE IT WAS STUCK. 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 AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE DEVICE ANALYSIS RESULTS; THE STENT WAS FOUND KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23518794 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page