Single Use Biliary Drainage Stent V PBD-1031-0711Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170346439), received between Oct 8, 2024 and Oct 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Migration; Migration

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFE PERFORMANCE OF TRACK DILATION AND BILE ASPIRATION WITH ERCP CATHETER IN EUS-GUIDED HEPATICOGASTROSTOMY WITH PLASTIC STENTS: A RETROSPECTIVE MULTICENTER STUDY." LITERATURE SUMMARY ABSTRACT OBJECTIVES: ENDOSCOPIC-ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) WITH PLASTIC STENT PLACEMENT IS ASSOCIATED WITH A HIGH INCIDENCE OF ADVERSE EVENTS THAT MAY BE REDUCED USING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CONTRAST CATHETER IN THE TRACK DILATION STEP. IN THIS STUDY, WE EVALUATED THE USEFULNESS OF TRACK DILATION AND BILE ASPIRATION PERFORMED WITH AN ERCP CONTRAST CATHETER IN EUS-HGS WITH PLASTIC STENT PLACEMENT. METHODS: IN A MULTICENTER SETTING, 22 EUS-HGS CASES DILATED WITH AN ERCP CONTRAST CATHETER WERE ANALYZED RETROSPECTIVELY AND COMPARED BETWEEN A BILE ASPIRATION GROUP AND NO BILE ASPIRATION GROUP. RBO WAS DEFINED AS THE RECURRENCE OF OBSTRUCTIVE JAUNDICE AND/OR CHOLANGITIS DUE TO STENT OCCLUSION OR MIGRATION. ADVERSE EVENTS OTHER THAN RBO WERE CATEGORIZED AS POST-PROCEDURE COMPLICATIONS, WHICH INCLUDED BILE LEAKAGE, PERITONITIS, BLEEDING, PERFORATION, PANCREATITIS, CHOLECYSTITIS, ASPIRATION PNEUMONIA, LIVER

  Patient problems: Obstruction/Occlusion

  MAUDE report 20397085 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFE PERFORMANCE OF TRACK DILATION AND BILE ASPIRATION WITH ERCP CATHETER IN EUS-GUIDED HEPATICOGASTROSTOMY WITH PLASTIC STENTS: A RETROSPECTIVE MULTICENTER STUDY." LITERATURE SUMMARY: ABSTRACT OBJECTIVES: ENDOSCOPIC-ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) WITH PLASTIC STENT PLACEMENT IS ASSOCIATED WITH A HIGH INCIDENCE OF ADVERSE EVENTS THAT MAY BE REDUCED USING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CONTRAST CATHETER IN THE TRACK DILATION STEP. IN THIS STUDY, WE EVALUATED THE USEFULNESS OF TRACK DILATION AND BILE ASPIRATION PERFORMED WITH AN ERCP CONTRAST CATHETER IN EUS-HGS WITH PLASTIC STENT PLACEMENT. METHODS: IN A MULTICENTER SETTING, 22 EUS-HGS CASES DILATED WITH AN ERCP CONTRAST CATHETER WERE ANALYZED RETROSPECTIVELY AND COMPARED BETWEEN A BILE ASPIRATION GROUP AND NO BILE ASPIRATION GROUP. RBO WAS DEFINED AS THE RECURRENCE OF OBSTRUCTIVE JAUNDICE AND/OR CHOLANGITIS DUE TO STENT OCCLUSION OR MIGRATION. ADVERSE EVENTS OTHER THAN RBO WERE CATEGORIZED AS POST-PROCEDURE COMPLICATIONS, WHICH INCLUDED BILE LEAKAGE, PERITONITIS, BLEEDING, PERFORATION, PANCREATITIS, CHOLECYSTITIS, ASPIRATION PNEUMONIA, LIVE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Peritonitis

  MAUDE report 20397083 ↗