Beacon G31215Recalls & reported problems
Cook Incorporated · Beacon Tip Centimeter Sizing Catheter · Class 2
All models of Beacon (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002312159), received between Apr 18, 2016 and Apr 18, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2016Material Separation; Material Separation
THE PHYSICIAN OF INTERVENTIONAL RADIOLOGY DID A PROCEDURE ON (B)(6) 2016 USING A COOK BEACON TIP VESSEL SIZING CATHETER. WHILE REMOVING THE DEVICE FROM THE PATIENT, THE PIGTAIL BEGAN TO BREAK UP (SEPARATE). CONSEQUENTLY, THE PATIENT WAS SENT TO THE OPERATING ROOM FOR FINAL RETRIEVAL OF THE PART/PIECES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5584896 ↗
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, ClassifiedBeacon 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, ClassifiedBeacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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