Advanix™ Biliary M00534600Recalls & reported problems
Boston Scientific Corporation · Biliary Stent with NaviFlexTM RX Delivery System · Class 2 · Implant
All models of Advanix Biliary (59)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729787150), received between Mar 20, 2025 and Jun 1, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Deformation1
- Migration1
- Positioning Failure1
Patient problems
- Biliary Leak1
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 20, 2025Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNSPECIFIED DATE. DURING THE PROCEDURE THE STENT WAS UNABLE TO BE DEPLOYED. THERE WAS 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 A GUIDE CATHETER AND PULL WIRE DETACHMENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652679 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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