BeaconRecalls & reported problems across all models
Cook Incorporated · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Beacon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 6 models of Beacon by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2016 and Mar 30, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Beacon recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 2, 2026Open, Classified
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1936-2026 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
Most reported Beacon problems
Device problems
- Material Separation2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Beacon models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Beacon G31216Catheter, intravascular, diagnostic1 recall1 report
- Beacon G31213Catheter, intravascular, diagnostic1 recall0 reports
- Beacon G31214Catheter, intravascular, diagnostic1 recall0 reports
- Beacon G31220Catheter, intravascular, diagnostic1 recall0 reports
- Beacon G31221Catheter, intravascular, diagnostic1 recall0 reports
- Beacon G31215Catheter, intravascular, diagnostic1 report
Recent Beacon adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 2017Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE COOK ALPHA ABDOMINAL SYSTEM USING THE BEACON TIP AUROUS CENTIMETER VESSEL SIZING CATHETER X. THE PROCEDURE WAS COMPLETED ACCORDING TO PLAN. DURING THE POST-OP CT, SOMETHING STRANGE WAS OBSERVED INSIDE THE LUMEN OF THE STENTGRAFT. IT CAN BE SEEN IN ALL PROJECTIONS BUT SAGITTAL AND AXILLARY ARE MOST CLEAR. IT STARTS AT THE UPPER LEVEL OF THE BARE STENT (ZIMB) AND GOES INSIDE THE LUMEN DOWNWARDS. IT BIFURCATES AND CONTINUES DOWN EACH COMMON ILIAC. IT WAS DETERMINED THAT A FRAGMENT OF THE DEVICE, THE PEEL AWAY SHEATH, WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AT THE TIME OF THE PROCEDURE, HOWEVER THE PATIENT IS GOING TO REQUIRE AN ADDITIONAL PROCEDURE TO REMOVE THE DEVICE PORTION. THIS WAS NOT IDENTIFIED AT THE TIME OF THE PROCEDURE. THE PLAN IS NOW TO TAKE THE PATIENT BACK TO THE HOSPITAL AND SEE IF THEY CAN VISUALIZE AND POSSIBLY EXTRACT IT. THIS IS STILL IN PLANNING AND AT THE TIME OF THIS REPORT, NO SECONDARY PROCEDURE HAS YET BEEN SCHEDULED OR COMPLETED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6446475 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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