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Torcon NB G07268Recalls & reported problems

Cook Incorporated · Torcon NB, Advantage Catheter · Class 2

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 00827002072688), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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-0448-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 4, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    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 12568198 ↗

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.