RX Biliary M00545630Recalls & reported problems
Boston Scientific Corporation · Biliary Stent with RX Delivery System · Class 2 · Implant
All models of RX Biliary (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729301813), received between Jun 11, 2026 and Jun 11, 2026 — classified as 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
- Device Dislodged or Dislocated1
- Difficult to Advance1
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.
MalfunctionJun 11, 2026Break; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT WAS INTENDED TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH DUAL STENT PLACEMENT, PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE ADVANCING THE DELIVERY SYSTEM THROUGH THE SCOPE, THE GUIDEWIRE DISLODGED FROM THE CATHETER, LEADING TO COMPLICATIONS. ADDITIONALLY, BOTH THE GUIDE CATHETER AND PUSH CATHETER BROKE. AS A RESULT, THE DELIVERY SYSTEM WAS REMOVED FROM THE SCOPE, AND ALL WIRES WERE WITHDRAWN TO ALLOW THE PROCEDURE TO BE RESTARTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480001 ↗
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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 13, 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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