Cook Incorporated has recalled 26,986 Beacon Tip 5.0 Fr Angiographic catheters due to identifying that affected device lots may experience tip separation. These catheters are used in medical procedures to assist in diagnosing and treating conditions in blood vessels. The recall covers various configurations, including different shaft lengths, tip shapes, and catheters with specialized hydrophilic coatings. While no injuries have been reported in this notice, tip separation is a critical defect that can lead to serious patient harm. Medical facilities should stop using the affected lots immediately and contact the manufacturer or their supplier.
The catheter tip may separate or detach from the device during use inside a patient's body. If this occurs, it can cause the fragment to block blood vessels, damage the vessel walls, or require further medical intervention or emergency surgery to retrieve the detached piece.
Quantity: 26986 units. Reference Product Numbers (RPN) and Global Product Numbers (GPN) used to identify specific catalog configurations.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.