Single Use Biliary Drainage Stent V PBD-1030-1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170346170), received between Oct 4, 2024 and Feb 24, 2025 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT THE STENT WAS TORN OFF ON ONE SIDE AND DAMAGED IN THE PATIENT WHEN REMOVING IT WITH A SNARE (UNKNOWN MANUFACTURER) AFTER 12 WEEKS OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. FOLLOW-UP CONFIRMED THAT NO ADDITIONAL SURGERY OR ADDITIONAL INTERVENTION WAS REQUIRED DUE TO THE DAMAGED STENT. THERE WAS NO CHANGE IN HEALTH STATUS DUE TO THE REPORTED EVENT AND PATIENT WAS DISCHARGED. NO ADDITIONAL TRAUMA AND NO PATIENT HARM WAS REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444743 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AUTHOR THAT THE RISK OF COMPLICATIONS WAS LOW OR NOT SIGNIFICANTLY DIFFERENT FROM THE CONTROL STENT. IT IS UNLIKELY THAT THE OLYMPUS DEVICE CAUSED (OR WAS RELATED TO) THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cholangitis; Fistula; Pancreatitis; Unspecified Infection

  MAUDE report 20372661 ↗
• InjuryOct 4, 2024Obstruction of Flow; Migration; Obstruction of Flow; Migration

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARISON OF DOUBLE-LAYER LARGE-DIAMETER AND CONVENTIONAL SMALL-DIAMETER PLASTIC STENTS FOR PREOPERATIVE BILIARY DRAINAGE IN RESECTABLE DISTAL MALIGNANT BILIARY OBSTRUCTION." LITERATURE SUMMARY: THE USE OF A PLASTIC STENT (PS) IN RESECTABLE PATIENTS WITH DISTAL MALIGNANT BILIARY OBSTRUCTION (DMBO) IS UNCOMMON DUE TO THE HIGH FAILURE RATE OF THIS METHOD. THIS STUDY EVALUATED THE EFFICACY AND SAFETY OF A DOUBLE-LAYER, LARGE-DIAMETER PS AS A BRIDGE TO SURGERY COMPARED WITH A CONVENTIONAL PS. THIS WAS A SINGLE-CENTER RETROSPECTIVE COHORT STUDY. IN TOTAL, 129 CONSECUTIVE PATIENTS WITH DMBO UNDERWENT PANCREATICODUODENECTOMY BETWEEN JANUARY 2011 AND MARCH 2018. FIFTY-FIVE PATIENTS WHO PREOPERATIVELY UNDERWENT PLASTIC BILIARY DRAINAGE WERE ENROLLED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON STENT DIAMETER: A LARGE-DIAMETER PLASTIC STENT (LPS) GROUP AND A SMALL-DIAMETER PLASTIC STENT (SPS) GROUP. THE PRIMARY ENDPOINT WAS THE STENT PATENCY PERIOD, AND THE SECONDARY ENDPOINT WAS THE MEDICAL COST. THIRTY-SIX PATIENTS RECEIVED SPSS; 19 PATIENTS RECEIVED LPSS. THE PATENCY RATE UNTIL SURGERY WAS SIGNIFICANTLY HIGHER IN THE LPS GROUP THAN

  Patient problems: Jaundice; Obstruction/Occlusion

  MAUDE report 20372514 ↗