Beacon Tip Torcon NB G27852Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002278523), received between May 6, 2016 and Feb 1, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 other recalls 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.

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.

• InjuryFeb 1, 2017Material Separation; Material Separation

  DURING A TOCE PROCEDURE, THE CATHETER WAS PUSHED THROUGH A 0.035'' GUIDEWIRE TO THE HEPATIC ARTERY. AS THE CATHETER WAS ADVANCED TO THE COMMON ILIAC ARTERY, THE TIP BROKE FROM THE SHAFT. TO PREVENT TIP TRANSLOCATION INTO THE AORTA, THE DOCTORS INTERVENED TO REMOVED THE TIP. THE RETRIEVAL LASTED APPROXIMATELY TWO HOURS. NO FRAGMENTS REMAIN WITHIN THE PATIENT AND THE PATIENT WAS UNHARMED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294622 ↗
• InjuryFeb 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOGRAPHY OF THE LIVER THE TIP SEPARATED. THE CATHETER WAS ADVANCED TO THE HEPATIC ARTERY TO DELIVERY CONTRAST MEDIUM FOR IMAGING OF THE TURMOR AFTER TOCE. DURING THE MANEUVERING, THE TIP SEPARATED AT THE ENTRY AND THE TIP TRAVELED TO THE PULMONARY ARTERY. A TEAM OF DOCTORS ASSISTED WITH THE RETRIEVAL PROCESS, AND THE TIP WAS REMOVED. THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294584 ↗
• InjuryFeb 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT, THE CATHETER WAS PUSHED TO THE HEPATIC ARTERY WITH ASSISTANCE OF 0.035'' GUIDEWIRE. HOWEVER, WHEN CONTRAST MEDIUM WAS INJECTED THROUGH THE CATHETER WITH AROUND 300 PSI, THE DOCTORS ROTATED THE CATHETER AND THE TIP WAS SEPARATED BUT NOT COMPLETELY. A CARDIOVASCULAR DOCTOR ATTEMPTED TO RETRIEVE THE TIP BY USING PFM SNARE. THE TIP WAS RETRIEVED WHILE STILL PARTIALLY ATTACHED. THE RETRIEVAL TOOK HOURS MANEUVERING THE SNARE TO AVOID CAUSING DAMAGES TO THE BLOOD VESSEL AS WELL AS TO AVOID THE TIP FROM BREAKING OFF COMPLETELY. NO ADDITION DETAILS HAVE BEEN RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6294565 ↗
• InjuryMay 6, 2016Material Separation; Material Separation

  DURING THE TACE PROCEDURE ON (B)(6) MALE PATIENT, THE SURGEON SAID THAT THE TIP OF CATHETER WAS DETACHED INSIDE THE PATIENT BODY. IT FLOWED WITH BLOOD TO FEMORAL PROFOUND ARTERY. THE USER TRIED TO FETCH OUT THE BROKEN PART WITH GOOSENECK SNARE BUT FAILED. A SECOND ATTEMPT FAILED TO TAKE OUT THE DETACHED PART WITH GOOSENECK SNARE. X-RAY REVEALED THE DETACHED PART FELL INTO THE DEEP ARTERIAL BRANCH, WHERE IT COULD NOT BE FETCHED OUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5636576 ↗

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
• Z-1902-2025 · May 15, 2025 · Open, Classified
  Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include