The FDA has designated Cook Medical’s recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the highest severity level, due to risks of tip separation before or during patient use. This defect can lead to catheter fragmentation and embolization, posing serious health risks.
Cook Medical notified affected customers on May 15, 2025. An urgent field safety notice was also issued in Europe. To date, there have been three serious injuries reported and no deaths linked to the issue.
Beacon Tip catheters are used by trained physicians for angiographic imaging procedures and come in various shaft lengths, tip curves, and hydrophilic coatings.
This recall echoes a similar 2016 recall involving Beacon Tip technology, which affected about 4 million devices due to tip splitting.
Follow MEDWIRE.AI for updates on medical device safety and regulatory alerts.
