Beacon Tip Angiographic Catheter (Cook) – Tip Separation (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Cook Medical issued an URGENT: MECIAL DEVICE RECALL notice to its consignees on 05/15/2025 via Fed-Ex Standard Overnight mail. The notice explained the reason for the recall, risk to health, and requested the following actions be taken: "Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com." For questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. The firm issued an updated notice on 05/22/2025 with the updated UDIs for each product.