Torcon NB G09631Recalls & reported problems
Cook Incorporated · Torcon NB, Advantage Catheter · Class 2
All models of Torcon NB (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002096318), received between Oct 18, 2016 and Oct 18, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
1 FDA recall record name this device's identifier.
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 18, 2026.
Recalls naming this device
- Oct 21, 2019Class IITerminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0458-2020 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2016Material Separation; Material Separation
IT WAS REPORTED DURING A TRANSJUGULAR BIOPSY (BX) PROCEDURE THE 7FR SHEATH FRACTURED AT THE DISTAL TIP WHILE GAINING ACCESS THROUGH THE RIGHT HEPATIC VEIN IN THE LIVER OF A TORTUOUS ANATOMY. (180334-2016-01148). THE FRACTURE OF THE SHEATH LED TO BOTH THE MEMORY POLYP BASKETS (MPB) AND ANOTHER MANUFACTURERS GLIDE CATHETER DISTAL TIPS BEING SHEARED OFF AND REMAINING IN THE PATIENT, THE GLIDE CATHETER WAS RETRIEVED USING A SNARE. THE COOK MPB WAS LOCATED IN THE PULMONARY ARTERY AND UNABLE TO BE RETRIEVED..(1820334-2016-01149). THE DECISION WAS MADE TO LEAVE THE PIECE OF MPB CATHETER INSIDE THE PATIENT ANATOMY, AS IT CURRENTLY DOES NOT APPEAR TO POSE SERIOUS RISK TO THE PATIENT. FURTHERMORE, ATTEMPTS TO RETRIEVE WERE DETERMINED TO POSSIBLY YIELD A GREATER RISK THEN LEAVING IT AS IS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6038005 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H749085263001Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page