Torcon NB G10599Recalls & reported problems
Cook Incorporated · Torcon NB, Advantage Catheter · Class 2
Data updated Oct 13, 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 00827002105997), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 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-0464-2020 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2018Peeled/Delaminated
THE COMPLAINANT REPORTED THAT APPROXIMATELY 6 PIECES OF VINYL FLAKES (COATING) CAME OFF THE TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WHEN THE PACKAGE WAS OPENED DURING THE CASE. THE CATHETER DID NOT MAKE PATIENT CONTACT, AND THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8169993 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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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