Advanix™ Pancreatic Stent M00536390Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729857334), received between Oct 14, 2020 and Nov 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE USED IN THE PANCREAS TO TREAT A PANCREATIC CANCER WITH LIVER METASTASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE OUTER PLASTIC PACKAGING HAD MELTED TOGETHER WITH THE INNER PLASTIC PACKAGING THAT COVERED THE DEVICE. THE PHYSICIAN FELT UNCOMFORTABLE WITH THE STERILITY OF THE DEVICE AND DECIDED TO USE ANOTHER ADVANIX PANCREATIC STENT AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: PHOTOS OF THE DEVICE WERE PROVIDED SHOWING THE PLASTIC COVERING OF THE INNER STERILE POUCH WAS RIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18078658 ↗
• MalfunctionOct 15, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS RECEIVED OPEN ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PACKAGING OF AN ADVANIX PANCREATIC STENT WAS ALREADY OPENED AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED ON THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10682832 ↗
• MalfunctionOct 14, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS RECEIVED OPEN ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PACKAGING OF AN ADVANIX PANCREATIC STENT WAS ALREADY OPENED, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT, OR PROCEDURE INVOLVED ON THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10679151 ↗