Beacon Tip Torcon NB G09312Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002093126), received between Jan 18, 2019 and Apr 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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

• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED 17MAY2024. THE INTENDED ACCESS SITE WAS THE FEMORAL ARTERY, BUT THE DEVICE DID NOT MAKE IT THAT FAR AS THE CATHETER HUB BROKE OFF BEFORE ENTERING THE PATIENT. THE HUB OF THE CATHETER BROKE "CLEAN OFF" OF THE CATHETER BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS DUE TO THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162714 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE FOR GASTROINTESTINAL BLEEDING, THE HUB OF A BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED FROM THE DEVICE. THE HUB WAS REPORTED TO SEPARATE WHILE THE DEVICE WAS BEING ADVANCED ONTO ANOTHER MANUFACTURER'S 0.035 GUIDE WIRE WITH LITTLE FORCE. THE DEVICE DID NOT MAKE PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262259 ↗

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