Gretchen Wofford Sues Over SmartPort Catheter Defects
A product liability lawsuit alleges that a port catheter caused a severe fungal infection in a patient.
Updated on Oct. 30, 2026 in Healthcare
Plaintiff Gretchen Wofford has filed a product liability lawsuit against AngioDynamics and Navilyst Medical in California. The suit alleges her SmartPort device was manufactured with defective materials that led to a candida fungal infection.
Why it matters
The case highlights critical concerns regarding the safety of implantable port catheters, which are widely used for regular drug or fluid delivery. The litigation centers on claims that the manufacturers failed to properly warn patients about the risks of device fracture and degradation.
The lawsuit alleges that excessive barium sulfate in the polyurethane catheter design leads to premature material degradation. Reported complications for these venous access devices include device migration, infections, bleeding, and thrombosis.
The players
Gretchen Wofford
She is the Texas-based plaintiff who initiated the legal action against the medical device manufacturers.
AngioDynamics Inc.
This is a medical technology company that develops and manufactures products used for vascular access and specialized surgery.
Navilyst Medical Inc.
This company is a manufacturer of medical devices, including specialized components for venous access and catheter systems.
The details
Wofford claims that the SmartPort device, designed for long-term venous access, degraded faster than expected due to its composition. The complaint asserts that defendants failed to provide accurate warnings about these specific fracture risks to healthcare providers and patients.
Timeline
The lawsuit was formally filed in the U.S. District Court for the Southern District of California on October 22, 2026.
Market Landscape
This litigation occurs amidst ongoing industry scrutiny regarding the safety standards mandated by the Federal Food, Drug, and Cosmetic Act's medical device reporting requirements. The case marks a potential shift in how manufacturers are held accountable for material degradation in long-term venous access products.
Patients who currently rely on implanted port catheters for routine injections should consult their physicians regarding potential device-specific risks. The case may lead to updated clinical monitoring protocols or increased diagnostic vigilance for those with similar medical hardware.
The takeaway
Patients utilizing implanted medical devices should maintain detailed records of their treatment and any adverse physical symptoms. Being proactive in discussing known device risks with healthcare providers can help ensure earlier detection of potential malfunctions.
Further reading
For more on the broader medical regulatory environment, see the latest updates in California Healthcare.
Source note: This article includes information reported by AboutLawsuits.
