Beacon Tip Torcon NB G08444Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002084445), received between Apr 1, 2016 and Apr 1, 2016 — classified as 1 injury.

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 16, 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 · 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.

• InjuryApr 1, 2016Material Separation; Material Separation

  A (B)(6) MALE PATIENT, WHO HAS A LONG STANDING HISTORY OF CLAUDICATION AND PVD WAS ADMITTED INTO THE CCL FOR ANGIOPLASTY +/- STENTING TO THE LEFT SFA. RIGHT GROIN ACCESS WAS ACHIEVED USING THE SELIDINGER TECHNIQUE AND THE 6F SHEATH (ANOTHER MANUFACTURER) WAS INSERTED TO COMMENCE THE ANGIOGRAPHY. THE 5F COOK BEACON TIP CATHETER WAS INSERTED OVER THE ANOTHER MANUFACTURER'S WIRE AND DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED USING THE BEACON TIP CATHETER. ANGIOGRAPHY IMAGES SHOWED THAT THE PATIENT HAD A PROXIMAL SFA LESION JUST BELOW THE PROFUNDA. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BEACON TIP CATHETER FROM THE PATIENTS GROIN SO HE COULD INTRODUCE THE INTERVENTIONAL PRODUCTS TO TREAT THE SFA LESION, IT WAS NOTED THAT THE TIP OF THE BEACON TIP CATHETER HAD DETACHED FROM THE MAIN BODY AND IT WAS NOW DISLODGED IN THE PATIENTS LEFT COMMON ILIAC ARTERY. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED TIP OF THE CATHETER. THE 6F SHEATH (ANOTHER MANUFACTURER) WAS EXCHANGED FOR A 7F. DESTINATION AND THEY USED VARIOUS SNARES, FORCEPS AND TECHNIQUES TO REMOVE THE CATHETER TIP. AFTER 2 HOURS OF ATTEMPTING TO REMOVE THE BROKEN TIP, THE PHYSICIAN DECIDED TO "TRAP" THE CATHETER TIP WITHIN TH

  Patient problems: Foreign Body In Patient

  MAUDE report 5541572 ↗

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