This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
What to Do
On May 15, 2025, Cook sent all affected customers a letter recommending the following actions:
- 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.
- 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.
Reason for Recall
Cook has become aware that catheters supplied in the affected device lots may experience tip separation. This issue was identified through field complaints, with users reporting tip separation occurring both prior to and during patient contact.
If an affected product is used, potential patient harms such as catheter fragmentation and embolization may occur. Medical consequences associated with device fragmentation or separation may include sepsis, vessel perforation, thrombosis, embolism, cardiac arrythmia, and death.
Cook has reported three serious injuries and no deaths associated with this issue.
Device Use
Beacon Tip Catheters are intended for use in angiographic (blood vessel imaging) procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Cook Medical at FieldActionsNA@CookMedical.com or 800-457-9120.
Additional FDA Resources (listed in order of most to least recent):
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
