Advanix™ Biliary M00534660Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729787211), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Positioning Failure1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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