Class I

Medical Device Recall: 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 len

Cook Incorporated · May 15, 2025

Reason for Recall

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

Product Description

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).

Distribution

Worldwide distribution.

Quantity Affected

26986 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1902-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.