FDA issues early alert for BD catheters due to leaks

The FDA has issued an early alert regarding BD’s 4 Fr Single Lumen PowerPICC intravascular catheters after the company identified cracks from “material fatigue” in the device tubing, tied to 10 serious patient injuries. BD is advising customers to destroy unused units but not to explant devices already in use unless damage is suspected. The cracked catheters can lead to leaking fluids, bleeding, embolism, infection, or disruption in therapy, with the root cause traced back to an issue with the resin used in manufacturing.

This alert is part of the FDA’s early notification pilot program launched in November to inform the public more quickly about high-risk medical device problems. BD has now had two recalls highlighted under this program, the first being its Rotarex clot removal device linked to 30 injuries and four deaths. Other devices flagged in early alerts include endoscope accessories from Olympus, Calyxo’s CVAC systems, and Medline fluid delivery sets.