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Torcon NB G06108Recalls & reported problems

Cook Incorporated · Torcon NB, Advantage Catheter · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002061088), received between May 30, 2018 and Mar 25, 2021 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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-0440-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Material Separation1
  • Tear, Rip or Hole in Device Packaging1

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.

  • MalfunctionMar 25, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11569300 ↗
  • MalfunctionMay 30, 2018Material Separation; Material Separation

    IT WAS REPORTED THAT DURING AN ANGIOGRAPHY PROCEDURE, THE TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER FRACTURED AT THE TIP BUT REMAINED CONNECTED TO THE BODY OF THE CATHETER. THIS REPORTEDLY OCCURRED "BEFORE STARTING THE PROCEDURE"; THEREFORE, THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT. A NEW CATHETER WAS OPENED AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7554038 ↗

Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices

All CATHETER, INTRAVASCULAR, DIAGNOSTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.