Percuflex™ Biliary M00533670Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729181279), received between Apr 2, 2019 and Dec 23, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX BILIARY STENT WAS OPENED TO BE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PRE-PRODUCT INSPECTION, A FOREIGN SUBSTANCES WERE FOUND INSIDE THE PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2020: THESE PRODUCTS ARE OVER POUCHED (USING EXTERNAL VINYL TO PREVENT CONTAMINATION) WHEN PRODUCTS ARRIVE AT THE DISTRIBUTION CENTER FOR BUSINESS PURPOSE. THE FOREIGN MATTER REPORTED WAS FOUND BETWEEN OUTSIDE OF THE STERILE BARRIER, BUT INSIDE OF THE EXTERNAL VINYL POUCH.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11064524 ↗
• MalfunctionDec 23, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX BILIARY STENT WAS OPENED TO BE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PRE-PRODUCT INSPECTION, A FOREIGN SUBSTANCES WERE FOUND INSIDE THE PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 27, 2020: THESE PRODUCTS ARE OVER POUCHED (USING EXTERNAL VINYL TO PREVENT CONTAMINATION) WHEN PRODUCTS ARRIVE AT THE DISTRIBUTION CENTER FOR BUSINESS PURPOSE. THE FOREIGN MATTER REPORTED WAS FOUND BETWEEN OUTSIDE OF THE STERILE BARRIER, BUT INSIDE OF THE EXTERNAL VINYL POUCH.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11064523 ↗
• MalfunctionApr 2, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE STENT MIGRATED INTO THE BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475443 ↗
• MalfunctionApr 2, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE STENT MIGRATED INTO THE BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475440 ↗
• MalfunctionApr 2, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, THE STENT MIGRATED INTO THE BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475439 ↗