WallFlex™ Biliary M00570600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729759249), received between Oct 4, 2018 and Mar 17, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS USED TO TREAT A BILE DUCT CANCER DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT FROM THE OUTER PACKAGE AFTER IT WAS OPENED, THE SPRING AUTOMATICALLY JUMPED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628038 ↗
• InjuryOct 4, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 11, 2018 THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED IN THE BILE DUCT ON (B)(6) 2016, AS PART OF THE E7034 WALLFLEX BILIARY PREOP DRAINAGE NATX CLINICAL TRIAL. ACCORDING TO THE COMPLAINANT, ON (B)(4) 2016, BASELINE LIVER FUNCTION TESTS WERE TAKEN. ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS (ABOS) WAS CONDUCTED AND THE FOLLOWING SYMPTOMS WERE REPORTED: DARK URINE, JAUNDICE, NAUSEA/ VOMITING, AND ITCHING. A 2.6 CM ADENOCARCINOMIC TUMOR WAS FOUND IN THE HEAD OF THE PANCREAS. ON (B)(6) 2016, THE PATIENT UNDERWENT A STUDY STENT PLACEMENT IN AN INPATIENT SETTING. A BILIARY SPHINCTEROTOMY WAS PERFORMED DURING THE STENT PLACEMENT PROCEDURE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. THE 8MM X 40 MM WALLFLEX BILIARY UNCOVERED STENT WAS PLACED IN A SATISFACTORY MANNER. ON (B)(6) 2016, THE PATIENT EXPERIENCED CHOLANGITIS AND WAS HOSPITALIZED ON (B)(6) 2016. ON (B)(6) 2016, A NASO-BILIARY DRAIN WAS PLACED. ACCORDING TO THE COMPLAINANT, THERE WERE NO VISIBLE ABNORMALITIES SUCH AS OCCLUSION OR MIGRATION OF THE STENT BUT THE CHOLANGITIS WAS ALSO DEEMED "OBSTRUCTIVE CHOLANGITIS DUE TO STUDY STENT OCCLUSION". IT WAS ALSO RE

  Patient problems: Inflammation; Jaundice

  MAUDE report 7935939 ↗