Medical device manufacturer Cook Medical has withdrawn catheters from the market due to a defect that has been associated with three severe injuries.
In a significant move, Cook Medical has initiated a Class I recall - the most serious designation by the Food and Drug Administration (FDA) - of its Beacon Tip 5Fr angiographic catheters, starting from May 2025. The recall was prompted by reports of catheter tip separation, which can lead to serious clinical complications and potential harm to patients.
The recall notice, published by the FDA, highlights the risk of thrombosis, embolization, cardiac arrhythmia, vessel perforation, sepsis, and even death due to catheter fragmentation or separation. So far, three serious injuries have been reported, but no deaths have been linked to the issue.
The recall involves approximately 26,986 affected units of the Beacon Tip 5.0 Angiographic Catheters, which were cleared for use since 2017. The fault is linked to a manufacturing process deviation by one specific operator, causing the catheter tip to potentially detach.
Cook Medical has advised all users to immediately examine and quarantine any unused affected inventory, cease all distribution and clinical use of the recalled devices, share recall information with all relevant personnel and third parties who may hold the product, and report any adverse events to the FDA’s MedWatch Safety Information program.
This is not the first time Cook Medical has recalled Beacon devices due to the risk of tip separation. Previous recalls were initiated in 2015 and 2016. The FDA's recall notice also warns that if an affected product is used, potential patient harms such as catheter fragmentation may occur.
Healthcare providers are urged to stop the use of these devices and quarantine them to prevent harm. Ongoing vigilance and reporting to regulatory authorities are strongly encouraged. The FDA continues to monitor this situation closely and will provide updates as more information becomes available.
- Cook Medical's recall of Beacon Tip 5Fr angiographic catheters, initiated in May 2025, is a Class I recall, the most serious designation by the FDA.
- The recall was triggered by reports of catheter tip separation, which can potentially lead to a host of medical conditions such as thrombosis, embolization, cardiac arrhythmia, vessel perforation, sepsis, and even death.
- The fault lies in a specific manufacturing process deviation, causing the catheter tip to potentially detach, as stated in the recall notice published by the FDA.
- The recall involves approximately 26,986 units of Beacon Tip 5.0 Angiographic Catheters, which were cleared for use since 2017.
- AI-driven medical news platforms are reporting that Cook Medical has advised users to immediately examine and quarantine any unused affected inventory, cease all distribution and clinical use of the recalled devices, share recall information with all relevant personnel and third parties, and report any adverse events to the FDA’s MedWatch Safety Information program.
- The FDA's recall notice reminds healthcare providers that if an affected product is used, potential patient harms such as catheter fragmentation may occur, emphasizing the importance of vigilance and reporting to regulatory authorities.
- In the realm of health-and-wellness, medical-conditions, and therapies-and-treatments, this situation underscores the critical role of medtech safety regulations, with the FDA continuing to monitor the issue closely and provide updates as more information becomes available.
