Beacon G31216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002312166), received between Mar 30, 2017 and Mar 30, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 2, 2026Open, Classified

   Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

   Z-1936-2026 · Root cause: Under Investigation by firm · 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.

• InjuryMar 30, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE COOK ALPHA ABDOMINAL SYSTEM USING THE BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER X. THE PROCEDURE WAS COMPLETED ACCORDING TO PLAN. DURING THE POST-OP CT, SOMETHING STRANGE WAS OBSERVED INSIDE THE LUMEN OF THE STENTGRAFT. IT CAN BE SEEN IN ALL PROJECTIONS BUT SAGITTAL AND AXILLARY ARE MOST CLEAR. IT STARTS AT THE UPPER LEVEL OF THE BARE STENT (ZIMB) AND GOES INSIDE THE LUMEN DOWNWARDS. IT BIFURCATES AND CONTINUES DOWN EACH COMMON ILIAC. IT WAS DETERMINED THAT A FRAGMENT OF THE DEVICE, THE PEEL AWAY SHEATH, WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AT THE TIME OF THE PROCEDURE, HOWEVER THE PATIENT IS GOING TO REQUIRE AN ADDITIONAL PROCEDURE TO REMOVE THE DEVICE PORTION. THIS WAS NOT IDENTIFIED AT THE TIME OF THE PROCEDURE. THE PLAN IS NOW TO TAKE THE PATIENT BACK TO THE HOSPITAL AND SEE IF THEY CAN VISUALIZE AND POSSIBLY EXTRACT IT. THIS IS STILL IN PLANNING AND AT THE TIME OF THIS REPORT, NO SECONDARY PROCEDURE HAS YET BEEN SCHEDULED OR COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6446475 ↗

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-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