Cook Incorporated recalls Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters ar…

Recall date

May 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1902-2025

FDA classification

Class I

Brand / firm

Cook Incorporated

Sold / distributed

Worldwide distribution.

Why it was recalled

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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).