Miller G03421Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002034211), received between Apr 19, 2018 and Apr 19, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• InjuryApr 19, 2018Material Separation; Material Separation

  IT WAS REPORTED A MILLER DOUBLE MUSHROOM BILIARY STENT SET WAS DIFFICULT TO REMOVE IN AN ANTEGRADE DIRECTION WHILE STENTING THE BILE DUCT DUE TO CHOLANGITIS STRICTURE OF THE COMMON BILE DUCT. A SECTION FOR THE DEVICE REMAINED IN THE PATIENT AND WAS REMOVED IN TO THE SMALL BOWEL TO PASS. AS REPORTED, THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7443743 ↗
• InjuryApr 19, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING A BILIARY STENT REMOVAL THROUGH A PERCUTANEOUS ACCESS PORT, THE MILLER DOUBLE MUSHROOM BILIARY STENT WAS STUCK IN THE BILIODIGESTIVE ANASTOMOSIS AND DIFFICULT TO REMOVE. A SMALL PART OF THE STENT REMAINED IN THE SUBCUTANEOUS TISSUE WHICH REQUIRED A SMALL SKIN INCISION BE MADE TO REMOVE THIS FRAGMENT. AS REPORTED, THE PATIENT DEVELOPED EXTENSIVE CELLULITIS IN THE ABDOMINAL REGION AND REQUIRED INTRAVENOUS ANTIBIOTICS FOR AN EXTENDED PERIOD OF TIME.

  Patient problems: Cellulitis; No Code Available

  MAUDE report 7442516 ↗