Torcon NB G06749Recalls & 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
- 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 00827002067493), received between Dec 15, 2018 and Feb 18, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Contaminated During Manufacture or Shipping1
- Manufacturing, Packaging or Shipping Problem1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2022Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT UPON REMOVING A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER FROM THE BOX, THE DISTRIBUTOR FOUND A HAIR INSIDE THE DEVICE PACKAGING. AS REPORTED, THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13560502 ↗MalfunctionDec 15, 2018Break; Separation Problem
THE COMPLAINANT REPORTED THAT THE HUB OF THE TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS DAMAGED WHEN THE PACKAGE WAS OPENED. THE PHOTOGRAPH PROVIDED BY THE COMPLAINANT DISPLAYED A PARTIALLY SEPARATED HUB. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED INSTEAD, AND THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8167555 ↗
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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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