Torcon NB G10741Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002107410), received between Aug 28, 2019 and Feb 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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-0468-2020 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  AS REPORTED, A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS USED DURING A CARDIAC CATHETERIZATION AND AORTIC RADIOGRAPHY PROCEDURE. DURING THE PROCEDURE, AN UNSPECIFIED POWER INJECTOR WAS USED TO DELIVER CONTRAST MEDIA AT A PRESSURE OF EIGHT HUNDRED POUNDS PER SQUARE INCH (PSI), WITH A VOLUME OF FORTY CUBIC CENTIMETERS (CC) OVER TWO SECONDS. THE HUB OF THE CATHETER SEPARATED FROM THE CATHETER BODY DURING THIS PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SEPARATED CATHETER WITH A NEW UNSPECIFIED DEVICE. THE SEPARATED CATHETER WAS MANUALLY REMOVED FROM THE PATIENT BY HAND. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385581 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 20FEB2026. THE PROCEDURE INVOLVED AORTIC RADIOGRAPHY, AND THE CONTRAST MEDIA PRESSURE WAS AT 40CC FOR TWO SECONDS. THE HUB OF ONE DEVICE SEPARATED, NOT TWO AS ORIGINALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993734 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 14JAN2026. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. THE CATHETER WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S SHEATH, OVER ANOTHER MANUFACTURER¿S WIRE GUIDE. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. BECAUSE PART OF THE CATHETER SHAFT WAS OUTSIDE OF THE BODY WHEN THE HUB SEPARATED, THE CATHETER SHAFT WAS REMOVED BY HAND. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936201 ↗
• MalfunctionAug 28, 2019Material Puncture/Hole; Stretched; Material Puncture/Hole; Stretched

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940565 ↗