Torcon NB G08153Recalls & 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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002081536), received between Apr 2, 2020 and Apr 2, 2020 — classified as 1 malfunction.
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 16, 2026.
Recalls naming this device
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0451-2020 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2020Material Separation; Material Separation
AS REPORTED, UPON OPENING THE PACKAGE, THE "NEAR END TIP" OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS BROKEN. THE DEVICE DID NOT MAKE PATIENT CONTACT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9916143 ↗
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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 · each recall links to the FDA recall notice
- 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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