COOK G31590Recalls & reported problems
Cook Incorporated · FUSION OMNI ERCP CATHETER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002315907), received between Oct 2, 2017 and Oct 2, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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
- Material Protrusion/Extrusion1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A FUSION OMNI ERCP CATHETER. ZIPPING THE CATHETER WAS VERY DIFFICULT. THE CATHETER WAS DAMAGED. THE DEVICE WAS EVALUATED ON 09/07/2017. THE STIFFENING WIRE HAS PENETRATED OUT OF THE CATHETER NEAR THE DISTAL END OF THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6907277 ↗
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 G02847Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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