Beacon Tip Torcon NB G08583Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002085831), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2019Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  PATIENT RECEIVED AN IMPLANT VIA THE RIGHT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM (DVT/PE). PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, DEEP VEIN THROMBOSIS (DVT), EMBEDMENT, FAILED REMOVAL. PATIENT FURTHER ALLEGES BIPOLAR DISORDER AND POST TRAUMATIC STRESS DISORDER (PTSD). PER RETRIEVAL REPORT, (B)(6) 2016: SUCCESSFUL REMOVAL OF INFRARENAL IVC FILTER, INCLUDING PENETRATING FILTER LEG, AFTER APPROXIMATELY 1.5 YEARS DWELL TIME WITHOUT IMMEDIATE PROST-PROCEDURE COMPLICATION. PER CT, (B)(6) 2017: IVC FILTER IS PRESENT AND ONE OF THE TINES OF THE IVC FILTER IS SEEN PROTRUDING BEYOND THE IVC POSTERIORLY WITH TIP ABUTTING THE RIGHT RENAL HILUM. PER CT, (B)(6) 2016: IVC FILTER IS IN PLACE SLIGHTLY TILTED TOWARDS THE MIDLINE. PER RETRIEVAL REPORT, (B)(6) 2016: PATIENT SINGLE IVC. UNSUCCESSFUL FILTER RETRIEVAL WITH CRANIAL DEFLECTION OF A SINGLE STRUT. AN IVC FILTER WAS SEEN IN PLACE WITH ITS APEX TILTED TO THE LEFT. PER CT, (B)(6) 2016: STABLE METALLIC INFERIOR VENA CAVA FILTER. THE DISTAL TIP LIES IN THE INFERIOR VENA CAVA LUMEN INFERIOR TO THE LEVEL OF THE LEFT RENAL VEIN. AND AT THE LEVEL OF THE RIGHT RENAL VEIN. RE DEMONSTRATED IS A METALLIC STRUT IN

  Patient problems: Perforation of Vessels; Thrombosis; Vessel Or Plaque, Device Embedded In

  MAUDE report 8737561 ↗

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