Beacon Tip Torcon NB G09548Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002095489), received between May 2, 2016 and Jan 30, 2024 — classified as 2 injuries, 1 malfunction.

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

• InjuryJan 30, 2024Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 18605797 ↗
• MalfunctionOct 2, 2023Break; Break

  IN ADDITIONAL INFORMATION RECEIVED ON 17OCT2023, IT WAS REPORTED THAT THE ACCESS SITE WAS SCARRED DUE TO A PRIOR EVAR AND COMMON FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY. THE BEACON TIP CATHETER WAS ADVANCED INTO THE ABDOMINAL AORTA OVER A WIRE GUIDE THROUGH A COMMON FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY, RATHER THAN THE PRE-EXISTING EVAR STENT GRAFT AS ORIGINALLY REPORTED. THE BEACON TIP WAS NOT INSERTED OR ADVANCED THROUGH ANY TYPE OF SHEATH. A SUPER STIFF WIRE FROM ANOTHER MANUFACTURER WAS USED. THE PATIENT DID HAVE TORTUOUS ANATOMY, WHICH WAS WHY THE CATHETER WAS INSERTED OVER A WIRE FOR PURCHASE PRIOR TO INSERTION OF THE SHEATH. MILD RESISTANCE WAS FELT DURING INSERTION THROUGH SOFT TISSUE. SIMILAR RESISTANCE WAS EXPERIENCED DURING REMOVAL OF THE CATHETER. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. UPON RETURN OF THE COMPLAINT DEVICE, THE CATHETER SHAFT WAS SEPARATED AT THE TIP AND BELOW THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855321 ↗
• InjuryMay 2, 2016Material Separation; Material Separation

  DURING A SURGICAL PROCEDURE, THE TIP OF THE BEACON TIP CATHETER SEPARATED WITHIN THE PATIENT. THE SEPARATED TIP WAS RETRIEVED. ADDITIONAL INFORMATION REQUESTED, HOWEVER IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 5623942 ↗

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