After previous recalls, Beacon Tip Catheters cleared again by FDA

We are excited to share that we will be able to re-launch Beacon Tip Catheters in the U.S. sometime in the first quarter of 2018. After being off the market due to recalls in 2015 and 2016, the HNBR 5.0 Fr Beacon Tip Catheters have received new FDA clearance.

At the time of the recalls, there was not a clear root cause for the spike in occurrences of tip separation. Our investigation turned up a multifactorial cause for the spike:

• Environmental: A combination of high heat and humidity or vaporized hydrogen peroxide (VHP)
• Manufacturing: Variations in the tip production process

We have been able to address each of those factors in the new Beacon Tip submission, including new foil packaging and an improved process for more-consistently forming the catheter tips. To learn more about what happened with Beacon Tip, what we did, and our expectations moving ahead, visit the Beacon Tip home page on our intranet.

Our next step will be to transfer the new tip production processes and packaging to manufacturing. Once those are in place, we can build up stock so that we can launch the HNBR 5.0 Fr Beacon Tip Catheters in the first part of next year.

A few of our AI reps have asked if this clearance changes the guidelines on the Beacon Tip catheters currently being used only for advanced aortic cases. This new FDA clearance is for the new Beacon Tip catheters that come in foil packaging. Please follow the same regulations with the limited Beacon Tip release that have been in place.

If you have any questions, please send them to BeaconTip@CookMedical.com.