Torcon NB G05955Recalls & reported problems
Cook Incorporated · Torcon NB, Advantage Catheter · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002059559), received between Oct 22, 2018 and Jun 14, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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-0432-2020 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
- Material Separation1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, DURING INSPECTION, A FOREIGN DARK "PARTICLE" WAS FOUND INSIDE THE PACKAGING OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684169 ↗MalfunctionMay 24, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED, AFTER RECEIPT OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE AT THE DISTRIBUTION FACILITY, A PIECE OF HAIR WAS OBSERVED INSIDE OF THE SEALED PRIMARY PACKAGING. THIS WAS OBSERVED DURING INITIAL INSPECTION AND WAS NOT USED FOR PATIENT CARE. PER THE INITIAL REPORTER, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.
Patient problems: No Patient Involvement
MAUDE report 8640927 ↗MalfunctionOct 22, 2018Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 7993740 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.