FDA-Device2025-06-25Class I
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
Cook Incorporated
Hazard
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Sold states
Worldwide distribution.
Affected count
26986 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2025Don't want to check this manually?
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