Beacon Tip Torcon NB G13792Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002137929), received between Apr 5, 2016 and Apr 2, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (5 reports).

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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF A TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER SEPARATED. THE DEVICE WAS REQUIRED FOR A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE GRAFT WITH FENESTRATIONS FOR THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY (SMA), AND RIGHT RENAL ARTERY (RRA) WAS DEPLOYED. THE COOK BEACON TIP CATHETER WAS ADVANCED OVER A GLIDE WIRE INTO THE SMA AND GRAFT FENESTRATION. THE GLIDE WIRE WAS REMOVED, A CONTRAST RUN WAS PERFORMED, THEN A 260CM COOK ROSEN WIRE WAS ADVANCED THROUGH THE CATHETER. UPON REMOVAL OF THE CATHETER, THE CATHETER SEPARATED, LEAVING THE GRAY TIP INSIDE THE PATIENT'S MAIN SMA TRUNK. VARIOUS ATTEMPTS TO REMOVE THE TIP, INCLUDING SNARING AND ALLIGATOR FORCEPS, WERE UNSUCCESSFUL. AFTER 60-70 MINUTES, IT WAS DETERMINED THE TIP COULD NOT BE RETRIEVED FROM THE PATIENT. AS A RESULT, A BARE-METAL, SELF-EXPANDING STENT WAS DEPLOYED ADJACENT TO THE GRAFT TO "CAGE" THE CATHETER TIP BETWEEN THE STENT AND SMA WALL. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21752879 ↗
• MalfunctionDec 6, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866655 ↗
• InjuryJul 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER SEPARATED DURING A FISTULOGRAM. THE CATHETER WAS ADVANCED THROUGH TORTUOUS PATIENT ANATOMY BY TWO USERS. WHEN TRYING TO ACCESS THE TARGET AREA, THE BEACON TIP SEPARATED AT THE JUNCTION BETWEEN THE BEACON TIP AND THE REST OF THE CATHETER. A CUT DOWN WAS PERFORMED TO RETRIEVE THE SEPARATED PIECE OF THE DEVICE. IT WAS REPORTED THE PATIENT IS WELL. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831162 ↗
• InjuryMay 23, 2016Material Separation; Material Separation

  INTERVENTIONAL RADIOLOGIST WAS PERFORMING PORTAL VENOUS PRESSURE MONITORING AND THE TIP OF THE CATHETER PARTIALLY CAME APART FROM THE ACTUAL CATHETER. THE CATHETER TIP WAS SAFELY RETRIEVED FROM THE (B)(6) FEMALE PATIENT BY CAREFULLY PULLING BACK OVER THE WIRE AND PULLING BACK INTO THE SHEATH. THE TIP OF THE CATHETER THEN FELL OFF AS SOON AS IT WAS OUT. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT AS THE CATHETER TIP SEPARATED AFTER THE CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5673309 ↗
• InjuryApr 5, 2016Material Separation; Material Separation

  DURING THE CASE THE RADIOPAQUE TIP OF THE CATHETER BROKE OFF FROM THE SHAFT LEAVING THE TIP IN THE SUPERIOR MESENTERIC ARTERY. IT WAS COMPLETELY SNARED AND RETRIEVED. NO KNOWN ADVERSE EFFECT TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5548206 ↗