Beacon Tip Torcon NB G13783Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002137837), received between Mar 25, 2016 and Mar 25, 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.

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.

• InjuryMar 25, 2016Material Separation; Material Separation

  A HYBRID TEVAR BYPASS LCCA (LEFT COMMON CAROTID ARTERY)-LSCA (LEFT SUBCLAVIAN ARTERY) PROCEDURE WAS PERFORMED ON A (B)(6) MALE PATIENT WITH PRE-EXISTING CONDITION OF TAA (THORACIC AORTIC ANEURYSM). INFORMATION WAS PROVIDED THAT THE PATIENT CAME WITH A TAA BUT WITH NOT ENOUGH PROXIMAL LANDING ZONE. THE DOCTOR DECIDED TO DO HYBRID PROCEDURE. AFTER EMBOLIZATION PROCEDURE AT (B)(6), THE DOCTOR REMOVED THE VANSCHIE4 CATHETER FROM THE BODY OF THE PATIENT BODY AND NOTED THE TIP WAS MISSING. FLUOROSCOPY REVEALED THE TIP WAS LOCATED ABOVE THE COIL. THE DOCTOR ATTEMPTED TO SNARE THE FRAGMENTED TIP, BUT WAS UNSUCCESSFUL. THEREFORE, HE DECIDED TO TIE LSCA ABOVE THE TIP, HOPING THAT IT WILL THROMBOSE LATER. ADDITIONAL INFORMATION WAS REQUESTED. HOWEVER IS WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5526122 ↗