RX ERCP Cannula M00545770Recalls & reported problems
Boston Scientific Corporation · ERCP Cannula · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729268659), received between Jun 22, 2017 and Dec 16, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA WAS INTENDED TO BE USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. UPON CHECKING THE DEVICE OUTSIDE THE PATIENT, A HAIR WAS FOUND INSIDE THE PACKAGING. IT WAS REPORTED THAT THE DEVICE WAS NOT UNPACKED AND THERE WAS NO DAMAGE NOTICED ON THE DEVICE POUCH OR SEAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 20, 2023: NOTE: ONE OF THE PHOTOS PROVIDED BY THE CUSTOMER SHOWS THE COMPLAINT DEVICE INSIDE ITS ORIGINAL PACKAGING WITH A FOREIGN MATERIAL INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993603 ↗InjuryJun 22, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE END OF THE CATHETER FELL OFF DURING WIRE EXCHANGE. IT IS UNKNOWN IF THE RO MARKER DETACHED; HOWEVER, THE TIP OF THE CANNULA FELL OFF AND WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO INJURY TO THE PATIENT WAS REPORTED AT THE CONCLUSION OF THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6662555 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.