Medical Device MDL-3125 Actively Recruiting • S.D. California

AngioDynamics Port Catheter Lawsuit (SmartPort & Navilyst)

Growing litigation against AngioDynamics and Navilyst Medical alleging SmartPort and NMI Port catheters fracture and migrate due to design defects, causing serious injuries including embolization to the heart or lungs, bloodstream infections, and requiring emergency retrieval surgery. Cases primarily involve cancer patients.

Last Updated: May 1, 2026
16 min read
JPML Data Verified
8 sources cited

Key Takeaways

  • 375 cases pending with rapid growth since MDL creation in July 2024
  • 500+ FDA adverse event reports for AngioDynamics port products
  • Similar to Bard PowerPort MDL-3081 with 2,400+ cases
  • Cases primarily involve cancer patients requiring chemotherapy
  • Allegations include catheter fractures, migration to heart/lungs, and infections
375+
Pending Actions
500+
FDA Adverse Events
1.6%
Fracture Rate (Studies)
Jul 2024
MDL Created

Key Facts (May 2026)

Pending Actions 375 cases in federal MDL (May 2026)
Growth Rate 733% growth since MDL creation
Defendants AngioDynamics, Inc., Navilyst Medical, Inc.
Presiding Judge Hon. Jinsook Ohta (S.D. California)
MDL Created July 25, 2024
First Transfer October 3, 2024
FDA Adverse Events 500+ reports in MAUDE database (2020-2025)
Catheter Fracture Rate 0.1% - 1.6% per medical literature
Can You Still File? Yes, lawsuits are actively being filed

Case Growth Since MDL Creation

This newer MDL has seen steady growth since its creation in July 2024. Case count has increased 733% as cancer patients report catheter fractures and complications.

Oct 24
45
Nov 24
89
Dec 24
142
Jan 25
168
Feb 25
185
Mar 25
198
Apr 25
212
May 25
225
Jun 25
238
Jul 25
248
Aug 25
255
Sep 25
261
Oct 25
265
Nov 25
267
Dec 25
269
Jan 26
295
Feb 26
317
Mar 26
344
Apr 26
357
May 26
375

Source: JPML MDL Statistics Reports, October 2024-May 2026

Related Litigation: Bard PowerPort (MDL-3081)

This MDL involves similar allegations to the larger Bard PowerPort MDL-3081 with 2,400+ pending cases. Both involve port catheter fractures, migrations, and infections primarily affecting cancer patients.

Source: JPML MDL Statistics Report, March 2026

1 What Is This Lawsuit About?

An implantable port (also called port-a-cath or TIVAP) is a medical device surgically placed under the skin to provide long-term vascular access for chemotherapy, IV medications, and blood draws. The device consists of a port body (reservoir) placed in the chest and a catheter tube that runs into a large central vein near the heart.

Plaintiffs allege that AngioDynamics SmartPort and Navilyst NMI Port devices are defectively designed. The catheters allegedly fracture spontaneously or at connection points, allowing fragments to migrate through the bloodstream to the heart or pulmonary arteries—requiring emergency surgical retrieval.

The lawsuits also allege the devices are prone to catheter-related bloodstream infections (CRBSIs), sepsis, and thrombosis (blood clots). These complications are particularly dangerous for cancer patients who are already immunocompromised from treatment.

Primarily Affects Cancer Patients: Port catheters are most commonly implanted in cancer patients receiving chemotherapy, making this litigation particularly significant for vulnerable patients already battling serious illness.

2 Products at Issue

The litigation involves port catheter products manufactured by AngioDynamics and its Navilyst Medical subsidiary:

AngioDynamics Products

  • SmartPort+ — Implantable ports (510(k) K190559)
  • SmartPort CT Series — Power-injectable port systems
  • SmartPort CT Vortex — Low profile titanium ports
  • BioFlo Products — Vascular access products with BioFlo technology

Navilyst Medical Products

  • NMI Port — Implantable port system (510(k) K122767)
  • NMI Port II — Second generation port (510(k) K153228)
  • NMI Dual Port II — Dual lumen port (510(k) K151239)

3 Reported Complications & Injuries

The FDA MAUDE database contains over 500 adverse event reports for AngioDynamics port products from 2020-2025. Reported complications include:

Catheter Fracture & Migration

  • Spontaneous catheter fracture inside the body
  • Fragments embolize to heart or pulmonary arteries
  • Incidence rate: 0.1% - 1.6% per medical literature
  • Requires interventional radiology retrieval

Bloodstream Infections

  • Catheter-related bloodstream infections (CRBSI)
  • Sepsis (life-threatening systemic infection)
  • Bacteremia requiring hospitalization
  • Especially dangerous for immunocompromised patients

Blood Clots (Thrombosis)

  • Deep vein thrombosis (DVT)
  • Pulmonary embolism risk
  • Port occlusion requiring intervention

Other Complications

  • Pinch-off syndrome (catheter compression)
  • Cardiac arrhythmias from fragments
  • Catheter disconnection from port body
  • Death (in severe cases)

4 FDA Regulatory History

Dec 2007
SmartPort CT MP 510(k) Clearance

FDA clears SmartPort CT MP Port Access System (K072375). Class II device cleared without clinical trials.

2008-2020
Multiple 510(k) Clearances

Multiple SmartPort and NMI Port variants cleared including CT Series, Vortex, low profile titanium, and dual port versions.

Oct 2011
Class 2 Recall: Smart Port CT

FDA recall of 8F Smart Port CT products (Catalog Numbers CT80STPD and CT80STPD-NF).

Apr 2021
Class 2 Recall: Sterility Issues

FDA recall (Z-1466-2021) of Smart Port CT products for potential compromised sterility due to Valved Introducers susceptible to failure.

Ongoing
500+ Adverse Event Reports

FDA MAUDE database contains over 500 adverse event reports for AngioDynamics products (2020-2025), including fractures, migrations, and infections.

510(k) Clearance Pathway: Port catheter devices were cleared through the FDA's 510(k) process, which allows devices to be marketed if "substantially equivalent" to existing devices—without requiring clinical trials demonstrating safety and effectiveness.

5 Do You Qualify for Compensation?

You may be eligible to file a claim if you meet these criteria:

Eligibility Requirements

  • Had an AngioDynamics or Navilyst port implanted — Including SmartPort, SmartPort CT, NMI Port, BioFlo, or similar products
  • Experienced a qualifying complication — Catheter fracture, fragment migration/embolization, bloodstream infection/sepsis, deep vein thrombosis, or required surgical removal
  • Can document the device and injury — Medical records showing device implantation and subsequent complications
  • Within statute of limitations — Generally 2-3 years from injury discovery, varies by state
New MDL Accepting Cases: This MDL was created in July 2024 and is actively accepting new cases. With pretrial proceedings ongoing, now is an optimal time to file if you experienced complications with an AngioDynamics or Navilyst port catheter.

6 Frequently Asked Questions

What is an implantable port catheter?
An implantable port (also called port-a-cath or TIVAP) is a medical device surgically placed under the skin, typically in the upper chest. It connects to a large central vein and provides long-term access for chemotherapy, IV medications, and blood draws. Ports can remain implanted for months or years.
What are the alleged defects?
Plaintiffs allege design defects that make the catheters prone to fracture, particularly at connection points or areas subject to compression (pinch-off syndrome). Allegations also include material degradation over time and susceptibility to infections.
What injuries are included in the lawsuit?
Qualifying injuries include catheter fracture and fragment migration to the heart or lungs, catheter-related bloodstream infections (CRBSI), sepsis, deep vein thrombosis, pulmonary embolism, cardiac complications from embolized fragments, and any complication requiring emergency surgical intervention or retrieval.
Who are the defendants?
The defendants are AngioDynamics, Inc. (a publicly traded medical device company headquartered in Latham, NY) and Navilyst Medical, Inc. (a corporate entity now integrated with AngioDynamics that manufactured NMI Port products).
How does this compare to the Bard PowerPort MDL?
MDL-3125 (AngioDynamics) and MDL-3081 (Bard PowerPort) involve similar allegations—catheter fractures, migrations, and infections in port devices primarily used by cancer patients. The Bard MDL is larger with 2,400+ cases and is further along in proceedings. Both MDLs are actively accepting new cases.
Have there been any settlements?
No settlements have been announced as of May 2026. The MDL was created in July 2024 and is still in early pretrial proceedings. Settlement discussions may begin after discovery progresses and bellwether trial selections are made.
Can I still file a lawsuit?
Yes, this MDL is actively recruiting new cases. If you experienced complications with an AngioDynamics SmartPort or Navilyst NMI Port and are within your state's statute of limitations (typically 2-3 years from injury discovery), you may be eligible to file.

Sources & References

8 official sources cited

• JPML MDL Statistics Report — Pending MDL Dockets (December 2, 2025)

• FDA 510(k) Premarket Notification Database — Device clearance records (K072375, K081472, K101017, K122767, K131694, K151239, K153228, K190559)

• FDA MAUDE Database — 500+ adverse event reports for AngioDynamics products (2020-2025)

• FDA Medical Device Recalls Database — Class 2 recalls (Z-1466-2021, October 2011)

• Burbridge B et al. "Catheter fracture and embolization associated with arm implantation of the cook vital port." Can Assoc Radiol J. 2013;64(3):269-73. (PMID: 22867962)

• D'Souza PC et al. "Complications and Management of Totally Implantable Central Venous Access Ports in Cancer Patients." Sultan Qaboos Univ Med J. 2021. (PMID: 33777430)

• SEC EDGAR Database — AngioDynamics company filings (CIK: 0001275187)

• U.S. District Court, Southern District of California — MDL-3125 case docket (3:24-md-3125)

Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. No attorney-client relationship is created by accessing or using this content.

Every case is unique, and results depend on the specific facts and circumstances involved. Past settlement amounts and case outcomes do not guarantee similar results in your case. If you believe you have a legal claim, you should consult with a licensed attorney in your jurisdiction who can evaluate your specific situation.

Read our full disclaimer · Privacy Policy · Terms of Use