Advanix BiliaryRecalls & reported problems across all models
Boston Scientific Corporation · 59 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 514
- Deaths reported
- 6
- Injuries reported
- 192
- Recalls
- 0
We found 59 models of Advanix Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 514 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Sep 29, 2026 — classified as 6 deaths, 192 injuries, 316 malfunctions.
The most frequently reported specific device problem is “Break” (309 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 Biliary problems
Device problems
- Break309
- Adverse Event Without Identified Device or Use Problem113
- Positioning Failure101
- Migration70
- Material Deformation67
- Use of Device Problem60
- Difficult to Remove28
- Entrapment of Device20
Patient problems
- No Clinical Signs, Symptoms or Conditions305
- No Consequences Or Impact To Patient106
- Perforation53
- Pain13
- Cholangitis11
- No Known Impact Or Consequence To Patient11
- Abdominal Pain8
- Fever6
Advanix Biliary models
59 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advanix™ Biliary M00534330CATHETER, BILIARY, DIAGNOSTIC3 deaths58 reports
- Advanix™ Biliary M00534340CATHETER, BILIARY, DIAGNOSTIC39 reports
- Advanix™ Biliary M00534320CATHETER, BILIARY, DIAGNOSTIC29 reports
- Advanix™ Biliary M00534280CATHETER, BILIARY, DIAGNOSTIC28 reports
- Advanix™ Biliary M00534350CATHETER, BILIARY, DIAGNOSTIC1 death27 reports
- Advanix™ Biliary M00532190CATHETER, BILIARY, DIAGNOSTIC25 reports
- Advanix™ Biliary M00534690CATHETER, BILIARY, DIAGNOSTIC24 reports
- Advanix™ Biliary M00534700CATHETER, BILIARY, DIAGNOSTIC23 reports
- Advanix™ Biliary M00534230CATHETER, BILIARY, DIAGNOSTIC1 death18 reports
- Advanix™ Biliary M00534290CATHETER, BILIARY, DIAGNOSTIC16 reports
- Advanix™ Biliary M00534240CATHETER, BILIARY, DIAGNOSTIC14 reports
- Advanix™ Biliary M00534210CATHETER, BILIARY, DIAGNOSTIC13 reports
- Advanix™ Biliary M00532970CATHETER, BILIARY, DIAGNOSTIC12 reports
- Advanix™ Biliary M00534270CATHETER, BILIARY, DIAGNOSTIC12 reports
- Advanix™ Biliary M00534220CATHETER, BILIARY, DIAGNOSTIC11 reports
- Advanix™ Biliary M00534360CATHETER, BILIARY, DIAGNOSTIC10 reports
- Advanix™ Biliary M00533000CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Biliary M00532210CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Biliary M00534680CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Biliary M00534200CATHETER, BILIARY, DIAGNOSTIC9 reports
- Advanix™ Biliary M00534650CATHETER, BILIARY, DIAGNOSTIC8 reports
- Advanix™ Biliary M00532220CATHETER, BILIARY, DIAGNOSTIC7 reports
- Advanix™ Biliary M00534300CATHETER, BILIARY, DIAGNOSTIC1 death7 reports
- Advanix™ Biliary M00532260CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Biliary M00534590CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Biliary M00534710CATHETER, BILIARY, DIAGNOSTIC6 reports
- Advanix™ Biliary M00534630CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Biliary M00534640CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Biliary M00534260CATHETER, BILIARY, DIAGNOSTIC5 reports
- Advanix™ Biliary M00533260CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00533380CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00532900CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00532960CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00532180CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00534570CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00534720CATHETER, BILIARY, DIAGNOSTIC4 reports
- Advanix™ Biliary M00533360CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Biliary M00534370CATHETER, BILIARY, DIAGNOSTIC3 reports
- Advanix™ Biliary M00532880CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00532910CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00533030CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00532160CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00532270CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00532290CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00534560CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00534580CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00534600CATHETER, BILIARY, DIAGNOSTIC2 reports
- Advanix™ Biliary M00533250CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00533350CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00533370CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532870CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532890CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532950CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532990CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00533010CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532230CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00532240CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00534620CATHETER, BILIARY, DIAGNOSTIC1 report
- Advanix™ Biliary M00534660CATHETER, BILIARY, DIAGNOSTIC1 report
Recent Advanix Biliary adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Use of Device Problem; Material Deformation; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940787 ↗InjurySep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722899 ↗MalfunctionSep 8, 2026Activation, Positioning or Separation Problem; Positioning Problem
It was reported to Boston Scientific Corporation that an Advanix-NaviFlex RX Biliary Stent was to be implanted in the common bile duct to treat a biliary obstruction during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026. During deployment of a plastic biliary stent into the left hepatic system, the stent was advanced and positioned as intended. The delivery system pullwire was retracted completely until the hard stop was reached, and the stent was able to be fully deployed. The guidewire was then subsequently removed. However, the suture loop did not release from the delivery system and became wrapped around the stent flange. As the delivery system was withdrawn, the attached suture loop pulled the stent out of the duct. Troubleshooting was performed to free the retained suture loop. Initial attempts to cut the suture using forceps were unsuccessful. A SpyBite device was then used to successfully cut the suture loop, releasing the stent from the delivery system. Following release, a rat-tooth forceps was used in an attempt to reposition the stent back into the duct; however, repositioning was unsuccessful. The stent was subsequently remo
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673194 ↗MalfunctionSep 4, 2026Entrapment of Device; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600554 ↗MalfunctionJul 30, 2026Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086832 ↗InjuryJul 30, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
It was reported to Boston Scientific Corporation that an Advanix RX Biliary Preloaded Stent was to be implanted in the left hepatic duct to treat stenosis during an Endoscopic Retrograde Cholangiopancreatography Procedure (ERCP) performed on (b)(6) 2026.During the procedure, resistance was encountered during stent deployment. It was noted that the internal metal guidewire of the delivery system had fractured and was no longer traversing the entire length of the catheter. As a result, the stent could not be deployed. During removal of the device, a portion of the black inner catheter became visible. The exposed portion was grasped with a snare; however, it fractured, and a segment remained attached to the stent. The push catheter was also reported to have fractured. The procedure was subsequently completed using another device of the same model. There were no patient complications reported as a result of this event and the patient condition following the procedure was reported to be good.Note: The Advanix Biliary stent had expired on (b)(6) 2025 but was used on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085280 ↗MalfunctionJul 29, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071247 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BLACK INTRODUCER GOT BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461023 ↗MalfunctionJun 2, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT BECAME LOOSE DURING PLACEMENT AND WAS DISLOCATED DURING DELIVERY. IN AN ATTEMPT TO RESOLVE THE ISSUE, THE PHYSICIAN TRIED TO ADVANCE THE GUIDING CATHETER TO MAINTAIN THE PROCEDURAL POSITION. HOWEVER, THIS WAS NOT SUCCESSFUL. AS A RESULT, THE PHYSICIAN HAD TO REMOVE THE STENT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT RETRACTED PRIOR TO DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "TO INITIATE DEPLOYMENT, ENSURE THE NAVIFLEX RX DELIVERY SYSTEM LOCKING MECHANISM IS UNLOCKED. RETRACT THE GUIDE CATHETER BY PULLING ON THE PULL WIRE CAP. THE STENT WILL BE RELEASED WHEN THE GUIDE CATHETER RO MARKER IS ALIGNED WITH THE PUSH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368557 ↗MalfunctionJun 2, 2026Break; Premature Activation; Difficult to Advance
NOTE: RELATED ADVANIX BILIARY STENT, AUTOTOME AND HYDRA JAGWIRE COMPLAINTS ARE BEING REPORTED UNDER RECORDS (B)(4) AND (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WERE ATTEMPTED TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY DEPLOYING TWO PLASTIC BILIARY STENTS OVER A HYDRAWIRE. THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE STENT/SUTURE/PUSHER ASSEMBLY. THE CUSTOMER RETRACTED THE BLACK GUIDE CATHETER TO REPOSITION IT PRIOR TO ADVANCING IT OVER THE WIRE AND ATTEMPTED DEPLOYMENT MULTIPLE TIMES WITHOUT SUCCESS. FORCE WAS SUBSEQUENTLY APPLIED, RESULTING IN SUTURE BREAKAGE AND STENT MISDEPLOYMENT. THE PROCEDURE WAS ABORTED AND NO STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363995 ↗MalfunctionJun 2, 2026Break; Premature Activation; Difficult to Advance
NOTE: RELATED ADVANIX BILIARY STENT, AUTOTOME AND HYDRA JAGWIRE COMPLAINTS ARE BEING REPORTED UNDER RECORDS (B)(4) AND (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WERE ATTEMPTED TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY DEPLOYING TWO PLASTIC BILIARY STENTS OVER A HYDRAWIRE. THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE STENT/SUTURE/PUSHER ASSEMBLY. THE CUSTOMER RETRACTED THE BLACK GUIDE CATHETER TO REPOSITION IT PRIOR TO ADVANCING IT OVER THE WIRE AND ATTEMPTED DEPLOYMENT MULTIPLE TIMES WITHOUT SUCCESS. FORCE WAS SUBSEQUENTLY APPLIED, RESULTING IN SUTURE BREAKAGE AND STENT MISDEPLOYMENT. THE PROCEDURE WAS ABORTED AND NO STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363989 ↗InjuryJun 1, 2026Migration
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WERE IMPLANTED IN THE COMMON BILE DUCT TO TREAT STONES AND STRICTURES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2026. REPORTEDLY, ONE OF THE TWO IMPLANTED PLASTIC BILIARY STENTS MIGRATED AND THE PROXIMAL END PERFORATED THE ABDOMINAL WALL OPPOSITE TO THE PAPILLA. AS A RESULT, THERE WAS BILIARY DRAINAGE INTO THE PERITONEAL CAVITY. YET NO PNEUMOPERITONEUM WAS REPORTED. THE PROCEDURE WAS RESCHEDULED TO TREAT THE PERFORATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Biliary Leak; Perforation
MAUDE report 25354980 ↗InjuryMay 28, 2026Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE INTO TWO PIECES. THEY USED FORCEPS TO REMOVE THE BROKEN GUIDE CATHETER, AND 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 25325155 ↗MalfunctionMay 21, 2026Break; Entrapment of Device; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO TREAT CHOLEDOCHOLITHIASIS DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE PATIENT UNDERWENT A SUCCESSFUL ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH COMPLETE STONE EXTRACTION AND SATISFACTORY DUCTAL CLEARANCE. AT THE CONCLUSION OF THE PROCEDURE, AN ATTEMPT WAS MADE TO PLACE THE ADVANIX BILIARY STENT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT REACHED THE ELEVATOR OF THE SCOPE, WHICH CAUSED THE STENT TO GET STUCK AND COULD NEITHER BE DEPLOYED NOR WITHDRAWN. THE PHYSICIAN ATTEMPTED SEVERAL TROUBLESHOOTING STEPS, INCLUDING ADVANCING AND RETRACTING THE DEVICE AND REMOVING THE GUIDEWIRE FROM THE SCOPE. DESPITE THESE EFFORTS, THE STENT REMAINED STUCK. THE PHYSICIAN THEN REMOVED THE ENTIRE SCOPE FROM THE PATIENT WITH THE STENT STILL TRAPPED INSIDE. AN ALTERNATE ERCP SCOPE WAS INTRODUCED, AND A NEW PLASTIC STENT WAS SUCCESSFULLY DEPLOYED. THE PATIENT EXPERIENCED NO COMPLICATIONS AND FULLY RECOVERED. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND IT SHOWED THAT THE ST
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248290 ↗MalfunctionMay 6, 2026Contamination; Packaging Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS RECEIVED ON (B)(6) 2026. IT WAS REPORTED THAT IN THE FRONT PART OF THE PACKAGE WAS DAMAGED UPON ARRIVAL AT THE HOSPITAL. THE INNER PACKAGING WAS OBSERVED TO BE CUT, AND AS A RESULT OF THE DAMAGE, THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT AS THE DEVICE WAS NOT USED DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106471 ↗
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