NA TCN-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813250013047), received between Feb 22, 2022 and Feb 22, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

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. Apr 29, 2026Open, Classified

   Reusable electrodes may not meet expected performance levels.

   Z-2403-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. May 30, 2019Terminated

   The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

   Z-1698-2020 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryFeb 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING STERILIZATION, BLOOD WAS NOTED INSIDE AND WAS OOZING OUT FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577616 ↗