FDA recall Z-1902-2025

Cook Incorporated · Class I · device

Product

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).

Reason for recall

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

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-05-15
Report date
2025-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1902-2025