Beacon Tip Torcon NB G08471Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002084711), received between Jul 1, 2015 and Feb 1, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 15, 2025Class IOpen, Classified

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

   Z-1902-2025 · Root cause: Process change control · Recall details · 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.

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

  IT WAS REPORTED DURING A CEREBRAL ANGIOGRAPHY PROCEDURE, UPON ENTRY TO THE SUBCLAVIAN ARTERY THE TIP BROKE OFF OF THE CATHETER. THE TIP TRAVELED TO PULMONARY ARTERY. THE PHYSICIAN INTERVENED BY USING A 3FRX12MM PFM SNARE TO RETRIEVE THE TIP FROM PULMONARY ARTERY. THE RETRIEVAL PROCEDURE TOOK AN ESTIMATED 4 HOURS AND THE TIP WAS RETRIEVED. IT IS NOTED THAT THE PATIENT WAS CONSCIOUS AT THE TIME OF THIS EVENT AND EXPERIENCED DISCOMFORT. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Pain

  MAUDE report 6294347 ↗
• InjuryJul 1, 2015Tip breakage

  THE DOCTOR REPORTED THAT HE WAS PERFORMING A ROUTINE CEREBRAL ANGIOGRAPHY PROCEDURE ON THE (B)(4) MALE PATIENT. THE PHYSICIAN WAS USING THE ANGIOGRAPHIC CATHETER AS PER INSTRUCTIONS FOR USE (IFU) GUIDELINES. AS HE WAS TORQUEING THE CATHETER (WITH THE GUIDE WIRE INSITU) THE CATHETER TIP BROKE OFF AND TRAVELED TO THE PATIENT'S ILIAC ARTERY. THE DR. SCRUBBED IN AND MANAGED TO RETRIEVE THE BROKEN TIP FROM THE PATIENTS VESSELS USING ANOTHER MANUFACTURER'S SNARE DEVICE. IT WAS REPORTED THE RETRIEVAL PROCESS TOOK APPROXIMATELY 2 HOURS. THE PATIENT WAS RETURNED TO THE WARD WHERE HE STAYED OVERNIGHT AND RETURNED TO RADIOLOGY THE NEXT DAY AND THE INITIAL PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: Foreign body, removal of; Other (for use when an appropriate patient code cannot be identified)

  MAUDE report 4898383 ↗

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