Recall Z-1902-2025— Cook Incorporated

Name: FDA recall Z-1902-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-15

Class I · Ongoing

Class I FDA medical device recall by Cook Incorporated, initiated 2025-05-15. It names one FDA 510(k) clearance: K173289. 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: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation..

Recalling firm: Cook Incorporated
Classification: Class I
Status: Ongoing
Initiated: 2025-05-15
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K173289 — Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing CatheterCook Incorporated·cleared 2017-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.