RX ERCP Cannula M00545780Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729268673), received between Aug 13, 2018 and Jan 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 29, 2026Difficult to Advance; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT 22008078 PERFORMED ON (B)(6) 2026. DURING THE PREPARATION, IT WAS REPORTED THAT THERE WAS PLASTIC (NOT PART OF THE CANNULA) INSIDE THE LUMEN OF THE CANNULA WHERE THE LUMEN GETS NARROWER. IT PROHIBITED A 0.035 OR A 0.025 WIRE FROM MAKING IT THROUGH THE LUMEN TO THE TIP OF THE CANNULA. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE UTILIZING A 0.018 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218177 ↗
• MalfunctionJan 29, 2026Difficult to Advance; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT 22008078 PERFORMED ON (B)(6) 2026. DURING THE PREPARATION, IT WAS REPORTED THAT THERE WAS PLASTIC (NOT PART OF THE CANNULA) INSIDE THE LUMEN OF THE CANNULA WHERE THE LUMEN GETS NARROWER. IT PROHIBITED A 0.035 OR A 0.025 WIRE FROM MAKING IT THROUGH THE LUMEN TO THE TIP OF THE CANNULA. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE UTILIZING A 0.018 GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218170 ↗
• MalfunctionAug 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE CLOSURE, THE X-RAY IMAGE SHOWED A DETACHED RADIOPAQUE (RO) MARKER FROM THE RX ERCP CANNULA WHICH WAS CONFIRMED AFTER THEY INSPECTED THE RX ERCP CANNULA AFTER USE AND NOTICED DAMAGE TO THE TIP OF THE CANNULA. REPORTEDLY, THERE WAS NO ATTEMPT MADE TO RETRIEVE THE RO MARKER AS IT WAS LOCATED IN THE LIVER TREE WHICH WAS FOUND TO BE VERY DIFFICULT TO RETRIEVE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7778664 ↗