FDA issues early alert for BD catheters due to leaks

On July 20, 2020, a sign for the Food and Drug Administration (FDA) was seen near its headquarters in Silver Spring, Maryland. In November, the FDA launched an early alert initiative to notify the public more quickly about medical devices with potential high-risk issues. Recently, BD advised customers to discard certain unused intravascular PowerPICC catheters after reports of 10 serious injuries. However, the company did not recommend removing catheters already in use unless damage is suspected. A March 11 recall letter cited increased cracking from “material fatigue” in the 4 Fr Single Lumen PowerPICC catheters, leading to leaks. Patient risks include fluid leakage, bleeding, infection, embolism, and interrupted therapy. BD attributed the issue to faulty resin in the catheter tubing and suggested alternative securement strategies. This is BD’s second device flagged by the FDA’s early alert program, which also includes alerts for Olympus, Calyxo, and Medline devices. The Rotarex device recall involved 30 injuries and four deaths.

28-04-2025