Beacon Tip Torcon NB G11484Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002114845), received between Feb 1, 2017 and Feb 1, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Separation” (3 reports).

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

1 other recall cover devices cleared under the same FDA submission (K173289); they may or may not involve this specific model.

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. May 15, 2025Open, Classified

   Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

   Z-1902-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2017Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  DURING A STANDARD ANGIOGRAPHY PROCEDURE, WHEN ADVANCING THE CATHETER INTO THE SUBCLAVIAN ARTERY, THE TIP BROKE FROM THE DEVICE AND IT TRAVELED TO THE AORTA. THE DOCTOR INTERVENED AND USED A 3F PFM MICROSNARE TO RETRIEVE THE TIP THROUGH THE ILIAC ARTERY. THE RETRIEVAL LASTED APPROXIMATELY 3 HOURS, THE TIP WAS REMOVED. THE PATIENT WAS UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294769 ↗
• InjuryFeb 1, 2017Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  WHEN THE DEVICE WAS INTRODUCED TO THE VESSELS WITH THE ASSISTANCE OF A 0.035'' GUIDEWIRE, THE CATHETER WAS ADVANCED TO THE HEPATIC ARTERY. UPON REACHING THE HEPATIC ARTERY, THE TIP BROKE. AS THE DOCTORS BEGAN TO REMOVE THE CATHETER, THE TIP TRAVELED TO THE PULMONARY ARTERY. THE PATIENT EXPERIENCED, PANIC, EXHAUSTION AND RAGE/ANGER. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294672 ↗
• InjuryFeb 1, 2017Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  IT WAS REPORTED, THAT DURING A TOCE PROCEDURE, UPON PUSHING THE COOK ANGIOGRAPHIC CATHETER TO THE ENTRY OF THE HEPATIC ARTERY THE TIP SEPARATED AND TRAVELED TO THE AORTA. THE PHYSICIANS INTERVENED USING 3F PFM SNARES TO RETRIEVE THE TIP. THE TIP WAS REMOVED, NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173289. One submission often covers many models, so check the product and lot details in each record.

• Z-1936-2026 · Apr 2, 2026 · Open, Classified
  Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20