Torcon NB G06005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002060050), received between Dec 17, 2018 and Dec 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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-0437-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2020Crack; Material Separation; Material Split, Cut or Torn; Crack; Material Separation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED 23DEC2020. THE TIP WAS CRACKED. THE DEVICE DID NOT SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11004141 ↗
• MalfunctionDec 17, 2018Material Separation

  THE COMPLAINANT REPORTED THAT THE TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED BETWEEN THE HUB AND THE BODY OF THE CATHETER WHEN IT WAS INSERTED INTO THE PATIENT'S BODY WITH THE WIRE. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170116 ↗