Advanix™ Pancreatic Stent M00537180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729856658), received between Jul 17, 2019 and Jul 17, 2019 — classified as 2 malfunctions.

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

• MalfunctionJul 17, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX PANCREATIC STENTS WERE RECEIVED BY AN ACCOUNT WITH A HOLE IN THE DEVICE PACKAGING. THIS CAUSED THE STERILITY OF THE DEVICE TO BECOME COMPROMISED. NO FURTHER ISSUES WERE REPORTED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED AT THE TIME THIS INCIDENT WAS NOTICED, AND THE DEVICE WAS NEVER OPENED OR USED BY THE ACCOUNT.

  Patient problems: No Patient Involvement

  MAUDE report 8800059 ↗
• MalfunctionJul 17, 2019Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX PANCREATIC STENTS WERE RECEIVED BY AN ACCOUNT WITH A HOLE IN THE DEVICE PACKAGING. THIS CAUSED THE STERILITY OF THE DEVICE TO BECOME COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED AT THE TIME THIS INCIDENT WAS NOTICED, AND THE DEVICE WAS NEVER OPENED OR USED BY THE ACCOUNT.

  Patient problems: No Patient Involvement

  MAUDE report 8800057 ↗