Port Catheter Lawsuits (MDL 3125): What the Record Shows

The port catheter lawsuits are a group of federal product liability actions consolidated as MDL No. 3125, In re: AngioDynamics, Inc., and Navilyst Medical, Inc., Port Catheter Products Liability Litigation, in the Southern District of California before Judge Jinsook Ohta. The Judicial Panel on Multidistrict Litigation created the proceeding by a transfer order filed October 3, 2024. The plaintiffs allege that the catheter component of the defendants’ implantable ports was manufactured with an excessive concentration of barium sulfate, which caused the material to degrade and the surface of the catheter to pit or crack. The Panel’s statistics report dated October 1, 2026 lists 439 actions pending out of 485 filed. No court has decided whether that allegation is true, no settlement appears in the documents reviewed here, and the FDA record reviewed here contains no action addressing the barium sulfate allegation.

What an implanted port catheter is

An implanted port is a device placed under the skin that gives repeated access to the bloodstream. FDA classifies it under product code LJT, “Port & Catheter, Implanted, Subcutaneous, Intravascular,” a Class II device reviewed through the 510(k) premarket notification pathway under 21 CFR 880.5965. The classification record describes it as a “subcutaneous, implanted, intravascular infusion port and catheter” and marks it as an implanted device. In use, the port sits in a pocket under the skin and the catheter attached to it carries fluids into a large central vein.

The FDA’s 510(k) records show specific products in this category. AngioDynamics’ Smart Port CT series port access systems (K101017) were cleared on June 17, 2010, and Navilyst Medical’s NMI Port (K122767) was cleared on April 30, 2013. Both records list product code LJT and regulation number 880.5965 and record a decision of “Substantially Equivalent.”

FDA recall records describe the intended use in the agency’s own words. A Smart Port CT record describes a device “indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.”

What is established versus what is alleged

Established by the documents reviewed: the existence of MDL No. 3125; the date and terms of the transfer order that created it; the court and judge it was assigned to; the districts and number of actions involved at the outset; the pending-case count as of October 1, 2026; the FDA classification of the device; the 510(k) clearance of specific products; and two FDA Class II recalls of these firms’ implantable ports for reasons other than barium sulfate.

Alleged, and not decided: that the defendants manufactured the catheter component of their port devices with an excessive concentration of barium sulfate; that this caused the material to degrade and the catheter surface to pit or crack; and that the catheters are therefore prone to fracture and to collect fibrinous blood products, which causes perforation, infections and blood clots, among other injuries. The Panel recorded all of that as the plaintiffs’ contention. It also recorded that the actions raise common questions of fact about the design, development, testing, manufacture, marketing and sale of the devices and about the warnings provided with them. Those are issues in the litigation, not findings.

Where the claims stand procedurally

The Panel transferred the actions under 28 U.S.C. § 1407, which allows coordinated or consolidated pretrial proceedings when actions pending in different districts share one or more common questions of fact. Transfer centralizes discovery and pretrial motions. It does not merge the claims into a single lawsuit, and it does not decide whether any claim has merit.

In the transfer order the Panel was choosing a district, not deciding the case. The plaintiffs asked for the Western District of Missouri. AngioDynamics, Inc. and Navilyst Medical, Inc. opposed centralization and suggested the Northern District of New York, the Southern District of California or the Middle District of Alabama as alternatives. PFM Medical, Inc. also opposed centralization, suggested the Southern District of California, and said it did not object to the Northern District of New York. The Panel selected the Southern District of California, noting that five involved actions were already pending there and that PFM Medical is headquartered in the district. It assigned the litigation to Judge Jinsook Ohta, who presided over one of the actions before the Panel.

The Panel also addressed the defendants’ argument that case-specific issues would predominate. The order records the defendants’ point that the actions involve multiple port product lines, each subject to a different FDA clearance, and a variety of different injuries. The Panel held that the statute contains no predominance requirement and that section 1407 requires only one or more common questions of fact.

The scale has grown since the order. Schedule A to the transfer order lists 23 actions in 16 districts, and the Panel recorded that it was aware of 33 potential tag-along actions in 19 districts; by the time the Panel ruled, it counted 56 actions pending in 28 districts. The Panel’s report dated October 1, 2026 records 439 actions pending in MDL No. 3125 out of 485 filed, within report totals of 162 dockets, 204,977 pending actions and 717,525 filed actions.

What the FDA record shows

The allegation at the center of the litigation is not one the FDA has acted on in the documents reviewed here. FDA device recall records for these firms’ implantable ports show Class II recalls for other reasons.

A BioFlo Port recall posted October 5, 2018 was initiated because the ports were “partially manufactured with the incorrect sterile port assembly,” according to the agency’s record. A Smart Port CT recall posted April 21, 2021 covered a specific batch of implantable infusion port kits and valved introducers that “may have potential for compromised sterility of the device,” the same database records. Both entries are recorded as Class II and both are marked terminated.

No FDA safety communication, recall or other regulatory action concerning barium sulfate concentrations in these catheters appears in the documents reviewed for this article.

Key dates

• June 17, 2010: FDA clears the AngioDynamics Smart Port CT series port access systems (K101017) as substantially equivalent (510(k) record).
• April 30, 2013: FDA clears the Navilyst Medical NMI Port (K122767) as substantially equivalent (510(k) record).
• October 5, 2018: FDA posts the Class II recall of BioFlo ports over the incorrect sterile port assembly (device recall record).
• April 21, 2021: FDA posts the Class II recall of a Smart Port CT batch over possible compromised sterility (device recall record).
• October 3, 2024: the Panel files the transfer order creating MDL No. 3125 and assigns it to Judge Jinsook Ohta in the Southern District of California (JPML transfer order).
• October 1, 2026: the Panel’s statistics report records 439 actions pending in MDL No. 3125 out of 485 filed (JPML statistics report).

What this does not establish

Nothing reviewed here shows a court finding that a port catheter caused any injury, that barium sulfate was present in an excessive concentration, or that any defendant did anything unlawful. The recall entries described above concern sterility and assembly issues, not the barium sulfate allegation, and a recall is not a finding that any person was harmed. No settlement has been approved, no trial has been held and no verdict appears in this record. A pending-case count measures filings, not merit. An MDL is also not a class action: cases transferred into one keep their individual plaintiffs unless a class is certified or a settlement resolves the claims together.

Frequently asked questions

Is there a port catheter settlement?

No settlement appears in the documents reviewed here. MDL No. 3125 remains in pretrial proceedings, and the most recent document in this record is the Panel’s pending-case report rather than any settlement or approval order.

Does an MDL make all the port catheter cases one lawsuit?

No. Under 28 U.S.C. § 1407 the Panel consolidates federal actions for coordinated or consolidated pretrial proceedings before one judge. Each plaintiff keeps an individual claim unless a class is certified or a settlement resolves the claims together. Background appears in MDLs compared with class actions and in how mass tort litigation works.

Which companies are named as defendants?

The Panel’s order names AngioDynamics, Inc., Navilyst Medical, Inc. and PFM Medical, Inc. as defendants. FDA recall records list the recalling firm for several port recalls as “AngioDynamics Inc. (Navilyst Medical Inc.).”

Has the FDA recalled these ports because of barium sulfate?

No such recall appears in the documents reviewed here. The port recalls found in FDA’s device recall records concern sterility and assembly problems. An allegation in a lawsuit and an FDA regulatory action are separate things, and this record shows only the allegation. The wider device picture appears in the medical device litigation hub and in the articles on hernia mesh litigation and the Philips CPAP and ventilator recall litigation.

Are new cases still being added to the MDL?

Yes, cases can be transferred into an MDL as tag-along actions, and the count has grown from the 23 actions on the transfer order’s Schedule A to 439 pending on October 1, 2026. That growth is a count of filings. It says nothing about how any claim will be decided. Readers documenting their own treatment and device records can use the guide on documenting a product injury claim.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “In re: AngioDynamics, Inc., and Navilyst Medical, Inc., Port Catheter Products Liability Litigation, MDL No. 3125, Transfer Order (October 3, 2024)” (link, accessed 2026-10-16)
2. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by District, Report Date 10/1/2026” (link, accessed 2026-10-16)
3. U.S. Food and Drug Administration: “Product Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular (Product Code LJT)” (link, accessed 2026-10-16)
4. U.S. Food and Drug Administration: “510(k) Premarket Notification K101017: Smart Port CT Series Port Access Systems” (link, accessed 2026-10-16)
5. U.S. Food and Drug Administration: “510(k) Premarket Notification K122767: NMI Port” (link, accessed 2026-10-16)
6. U.S. Food and Drug Administration: “Class II Device Recall Z-0076-2019: BioFlo Port with ENDEXO and PASV Technology” (link, accessed 2026-10-16)
7. U.S. Food and Drug Administration: “Class II Device Recall Z-1466-2021: Smart Port CT Implantable Port” (link, accessed 2026-10-16)

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