Torcon NB G05874Recalls & reported problems
Cook Incorporated · Torcon NB, Advantage Catheter · Class 2
All models of Torcon NB (79)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002058743), received between Mar 14, 2021 and Mar 14, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2021Material Separation; Material Separation
AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF ANOTHER MANUFACTURER¿S VASCULAR PLUG, A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A RIGHT PORTAL EMBOLIZATION PROCEDURE PRIOR TO A RIGHT HEPATECTOMY FOR HEPATO-CELLULAR CARCINOMA. WHEN AN X-RAY WAS OBTAINED, THE RADIOLOGIST NOTICED THAT THE OTHER MANUFACTURER'S EMBOLIZATION IMPLANT/VASCULAR PLUG HAD MIGRATED TOWARD THE HEART, AT THE LEVEL OF THE LEFT PULMONARY ARTERY. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR ATTEMPTED RETRIEVAL OF THE IMPLANT. THE COMPLAINT DEVICE, WHICH WAS USED TO CATHETERIZE THE RIGHT HEART CHAMBERS, SEPARATED DURING THE ATTEMPTED REMOVAL PROCEDURE. THE SEPARATED PORTION OF THE DEVICE AND THE EMBOLIZATION DEVICE WERE UNABLE TO BE RETRIEVED. THE PATIENT UNDERWENT A THORACOTOMY AND ARTERIOTOMY THE NEXT DAY TO RETRIEVE THE IMPLANT AND SEPARATED PORTION OF THE CATHETER FROM THE PULMONARY ARTERY. THROMBOSIS WAS REPORTED IN ALL ARTERIAL BRANCHES OF THE LEFT LOWER LOBE, REQUIRING ANTICOAGULATION FOR THREE MONTHS. THE HEPATECTOMY WAS POSTPONED AND MANAGEMENT OF CANCER WAS DELAYED.
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 11478799 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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