Beacon Tip Torcon NB G11517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002115170), received between Mar 10, 2016 and Apr 14, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2016Material Separation; Material Separation

  THROUGH RADIAL ARTERY CORONARY ANGIOGRAPH AND CAROTID ARTERIOGRAPHY ON (B)(6) YEARS OLD FEMALE PATIENT ON (B)(6) 2016. THE SURGEON TRIED TO ADVANCE THE CATHETER TO REACH THE CAROTID. THE TIP OF CATHETER WAS DETACHED. THE SECOND SURGERY WAS OPERATED ON (B)(6) 2016. THE SURGEON TOOK OUT THE DETACHED PORTION COMPLETELY THROUGH INTERNAL ILIAC ARTERIAL WITH UNKNOWN BRAND SNARE DEVICE. ADDITIONAL DETAILS PROVIDED ON 29MARCH2016: A (B)(6) YEAR-OLD FEMALE PATIENT WAS ADMITTED DUE TO "RECURRENT CHEST DISTRESS AND SYNCOPE FOR 8 YEARS AND RECURRENCE FOR 1 DAY" AND DIAGNOSED AS SYNCOPE WITH THE CAUSE REMAINED TO BE INVESTIGATED. SHE PERFECTED RELEVANT EXAMINATIONS AFTER ADMISSION. ON THE AFTERNOON OF (B)(6) 2016, SHE UNDERWENT TRANSRADIAL CORONARY ANGIOGRAPHY AND CAROTID ANGIOGRAPHY IN INTERVENTION ROOM. WHEN HOOKING THE CAROTID ARTERY WITH 5FR SIM2 ANGIOGRAPHIC CATHETER, THE CATHETER TIP FRACTURED AND FLOWED INTO THE LEFT INTERNAL ILIAC ARTERY. THE CHIEF PHYSICIAN OF USER FACILITY PERFORMED LEFT FEMORAL ARTERY PUNCTURE AND ARTERIOGRAPHY AND IDENTIFIED THAT THE CATHETER TIP WAS IN THE LEFT INTERNAL ILIAC ARTERY. A FRACTURE WAS FOUND ON THE REMOVED CATHETER AT THE WELDING POINT BETWEEN THE CATH

  Patient problems: No Code Available

  MAUDE report 5575993 ↗
• InjuryMar 10, 2016Material Separation; Material Separation

  A RIGHT ICA ANEURYSM EMBOLIZATION PROCEDURE WAS BEING PERFORMED ON THE (B)(6) FEMALE PATIENT; WHO HAD A TORTUOUS AND CALCIFIED ANATOMY. WHEN THE CATHETER WAS PLACED INTO THE RIGHT COMMON CAROTID ARTERY, IT WAS NOTED THAT THE TIP HAD BROKEN, BUT STILL REMAINED INTACT. THE USER REMOVED THE CATHETER AND CHANGED TO ANOTHER OF THE SAME DEVICE FROM THE SAME LOT. AGAIN, WHEN THE CATHETER WAS PLACED INTO THE RIGHT COMMON CAROTID ARTERY, THE TIP BROKE AGAIN, AND IT ALSO REMAINED INTACT. HOWEVER, AS THE USER ATTEMPTED TO REMOVE THE CATHETER; WHEN IT REACHED THE INTRODUCER SHEATH, THE TIP SEPARATED AND THE FRACTURED SEGMENT MIGRATED INTO THE SFA. THE FRAGMENTED SEGMENT WAS REMOVED WITH A SNARE. THE ANATOMY OF THE PATIENT WAS REPORTED TO HAVE BEEN CALCIFIED AND TORTUOUS. THE USER REPLACED THIS WITH ANOTHER CATHETER FROM THE SAME LOT AND COMPLETED THE PROCEDURE. NO INFORMATION PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 5492488 ↗

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