Which AngioDynamics Port Did You Get? How to Find Out

Why might my records name RITA, Navilyst or Boston Scientific?

AngioDynamics bought other port makers. In 2007 it bought RITA Medical, which held FDA clearance for a Vortex port. In 2012 it bought Navilyst, which was once part of Boston Scientific.

The RITA deal closed on January 29, 2007, and the Navilyst deal on May 22, 2012. Navilyst had been Boston Scientific’s fluid management and venous access business.

In its 2007 annual report, AngioDynamics listed its port lines. They included the Vortex family, LifePort, Triumph, Infuse-a-Port, OmegaPort, TitanPort and the Vortex MP.

In a court filing, AngioDynamics says Navilyst’s parent company later merged into AngioDynamics. One lawsuit quoted in that filing says a person got an AngioDynamics Vaxcel port in 2011. FDA cleared a Boston Scientific Vaxcel port system in 1998.

These names help you match your records to a company. They do not show whether your port had a problem.

How can I find out which port model I had?

Ask the hospital or clinic that put in your port for the procedure report and the device record. Port labels carry a code called a UDI. One part of it names the model, and another part can give the lot number.

The code is printed on the label and box in plain text and in a form a machine can read. That form is made so it can be entered into a patient record, so ask whether yours was. You can type the model part into AccessGUDID, a public FDA and National Library of Medicine database.

AccessGUDID lists 172 AngioDynamics records that match the word port. The brand names include BioFlo Vortex, Smart Port CT, BioFlo, Xcela, Lifeport and Vortex. Each record gives a model number and the catheter size.

A draft form in the court case asks people to list every port they have ever had. For each one, it asks the maker, the model and the dates it went in and came out.

What are AngioDynamics port catheters made of?

The catheter is the thin tube that runs from the port into a vein. FDA filings show that some models used silicone tubes and others used polyurethane, a kind of plastic. Both kinds have barium sulfate, a filler that lets the tube show up on X-rays.

FDA cleared the Vortex CT port in February 2007. Its filing says the silicone tube had 15% barium sulfate, with 25% in the tip. The SmartPort+ port, cleared in May 2020, uses a BioFlo tube made of a polyurethane called Carbothane. Its filing lists 30% barium sulfate in that tube, the same as for the SmartPort Plastic model.

AccessGUDID describes the tube for each model. For example, it lists silicone tubes for some Smart Port CT and Vortex LP systems, and polyurethane tubes for some Xcela Plus, BioFlo and Lifeport ports. We did not check every model.

These are the company’s own filings to FDA. They are not findings that any tube was faulty.

Talk to your doctor before any change to your port.

When did FDA clear the main AngioDynamics port lines?

FDA records show clearances for the Vortex CT in 2007 and the SmartPort CT series in 2008. Navilyst’s NMI Port was cleared in April 2013. The SmartPort+ followed in May 2020.

The BioFlo tube with Endexo was cleared earlier as part of Navilyst’s NMI Port II. FDA records also show a Navilyst NMI Dual Port II, cleared in June 2016. We did not find which FDA record covers each brand name used today, such as Xcela.

Where does PFM Medical fit in?

PFM Medical, Inc. is a separate company named in some of these cases. It is based in the same federal court district as the San Diego court. The draft court form covers ports made or sold by AngioDynamics or PFM Medical.

FDA records show PFM Medical had its own ports cleared, such as the T-Port HP in 2007. Navilyst listed PFM port clearances when it compared its NMI Port to ports already on the market. We found no record that says PFM made AngioDynamics or Navilyst ports.