What is the evidence that the port causes this?
No court has decided whether AngioDynamics ports caused these injuries. AngioDynamics says all implanted devices carry some risk of infection, breaks and clots. The cases ask whether these ports had those problems because of how the catheter was made.
In a 2016 lab study, researchers at Germany's Federal Institute for Materials Research and Testing and a Munich hospital examined catheters taken out of patients. They found that silicone catheters lost barium sulfate particles near the surface, leaving tiny notches where breaks could start. The study summary does not name the brands tested, and it does not show what happened to any one person.
A 2016 study from the same Munich hospital looked back at 698 ports placed in the forearm. Polyurethane catheters had more bloodstream infections and clots, while silicone catheters tended to break or come apart more often. It reviewed past records, so it shows patterns, not proof of cause.
At a German university hospital that placed 1,185 ports from 1997 to 2005, doctors found catheter clots in about 1 in 10 of them. They found broken catheters in fewer than 1 in 100. It was one hospital, and the summary does not compare brands.
A 2011 review of 57 studies found that port problem rates were measured in many different ways, from none to nearly half of devices. The reviewers said many of those studies were of poor quality.
FDA has listed recalls of some AngioDynamics ports, such as a 2022 Vortex MP recall over missing instructions. A 2021 Smart Port CT recall covered certain lots that might not be sterile. The port recall records we read were about labels, parts and packaging, not the catheter wearing down. FDA also says a problem report alone does not show that a device caused the problem.
