Cook G02847Recalls & reported problems
Cook Incorporated · Concord Endoscopic Cholangiography Set · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002028470), received between Dec 16, 2018 and Dec 16, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Device problems
- Fluid/Blood Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2018Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET WAS REMOVED FROM THE PACKAGE AND DURING PRIMING OF THE CATHETER, THE FLUID STARTED SPRAYING OUT OF THE SIDE BEFORE IT GOT TO THE DISTAL END OF THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167902 ↗MalfunctionDec 16, 2018Fluid/Blood Leak
IT WAS REPORTED THAT THE CONCORD ENDOSCOPIC CHOLANGIOGRAPHY CATHETER WAS LEAKING AT THE CONNECTION SITE WHEN BEING FLUSHED. ANOTHER DEVICE WITH THE SAME LOT WAS OPENED AND ENCOUNTERED THE SAME LEAKAGE PROBLEM. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE DEVICE WAS LEAKING AT THE HUB. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167900 ↗
Other CATHETER, CHOLANGIOGRAPHY devices
- PVC Thoracic Catheters 15028Atrium Medical Corporation · Catheter, Cholangiography1 recall0 reports
- Cook G08045Cook Incorporated · CATHETER, CHOLANGIOGRAPHY10 reports
- PVC Thoracic Catheters 8032Atrium Medical Corporation · Catheter, Cholangiography6 reports
- RX ERCP Cannula M00545780Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY3 reports
- Fanelli G12950Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- Reddick Scoop Tip Cholangiogram Catheter e2401-51Lemaitre Vascular, Inc. · Catheter, Cholangiography2 reports
- RX ERCP Cannula M00545770Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY2 reports
- Cook G03196Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.