Design and Material Defects in BioFlo Ports
The BioFlo Port’s catheter, intended for durability in high-pressure infusions, incorporates radiopaque barium sulfate for X-ray visibility, but plaintiffs claim concentrations exceed safe levels, creating stress points that propagate cracks over time.[1] This flaw, allegedly known since the device’s 2010s rollout, allows silicone degradation beneath the skin, leading to unnoticed fractures that embolize during routine access. Manufacturing inconsistencies, including uneven particle distribution, further compromise integrity, distinguishing BioFlo from competitors like Bard’s PowerPort, which faced similar but separate scrutiny.
AngioDynamics’ failure to redesign despite internal testing data—revealed in discovery—exacerbates claims of negligence, as the port’s Endexo technology, touted for thrombosis resistance, does little against structural brittleness.[2] Unlike low-profile variants like the BioFlo LP, standard models bear higher infusion demands, accelerating wear in oncology patients whose veins already suffer from sclerosing agents. These defects not only halt therapies but also seed emboli that lodge in lungs or hearts, transforming a supportive tool into a silent saboteur.
Regulatory Scrutiny and Recall History
No formal FDA recall has targeted BioFlo Ports, but the agency’s MAUDE database logs hundreds of adverse events since 2015, including 15% involving fractures and 20% infections, far above industry benchmarks.[3] In October 2024, the JPML centralized cases into MDL 3125 in California’s Southern District, now encompassing 218 filings as of September 2025, under Judge Jinsook Ohta to streamline pretrial proceedings.[4] This consolidation mirrors Bard PowerPort litigation, where over 2,000 suits settled for undisclosed sums, signaling potential for BioFlo resolutions.
AngioDynamics’ 2012 acquisition of Navilyst Medical inherited legacy designs, but critics argue post-market surveillance lagged, delaying warnings on barium risks despite a 2022 Cureus study flagging 10% complication rates across ports.[5] As 2025 bellwether trials loom, plaintiffs push for punitive measures, citing the company’s $300 million annual revenue from vascular devices amid unresolved hazards.
Injuries Stemming from BioFlo Port Failures
Patients implanted with BioFlo Ports endure a cascade of harms when catheters fracture or migrate, often undetected until emergencies arise. Key injuries from consolidated complaints include:
- Embolism and Thrombosis: Fragments blocking vessels cause pulmonary infarcts or strokes, as in an Oregon man’s acute embolism requiring embolectomy.[6]
- Severe Infections: Sepsis from bacterial ingress at fracture sites, like a Florida woman’s E. coli outbreak necessitating ICU stays.
- Cardiac Arrhythmias: Migrated pieces irritating heart walls, leading to palpitations or arrests in vulnerable chemo recipients.
- Organ Perforation: Catheter tips eroding tissues, resulting in hemothorax or pneumothorax demanding thoracotomy.
- Wrongful Death: Untreated emboli progressing to multi-organ failure, with families alleging preventable fatalities.
These outcomes, affecting over 10% of users per studies, interrupt cancer care and inflate bills by $50,000+ per revision, per MDL filings.[7] Oncology patients, already immunocompromised, face amplified mortality, turning a lifeline into a liability.
Symptoms of BioFlo Port Malfunctions
BioFlo failures often present insidiously, delaying diagnosis until crises unfold; vigilance for port-site cues is vital. Common symptoms from patient reports and MDL dockets include:
- Chest or Arm Pain: Sudden, sharp discomfort signaling migration or clot formation, worsening with infusion.
- Swelling and Erythema: Localized inflammation at the implant, progressing to abscesses or feverish chills.
- Dyspnea and Hemoptysis: Shortness of breath or coughing blood from pulmonary emboli.
- Arrhythmic Palpitations: Irregular heartbeats or syncope from intracardiac fragments.
- Neurological Deficits: Confusion, weakness, or vision loss from cerebral emboli.
Legal Basis for BioFlo Port Claims
Strict liability under 21 U.S.C. § 360k governs medical device suits, imputing defects to AngioDynamics without fault proof, as barium overload renders ports adulterated.[8] Failure-to-warn counts assail inadequate surgeon disclosures on fracture risks, breaching FDA PMA conditions despite known MAUDE spikes. Limitations periods (1-3 years post-discovery) toll via fraudulent concealment, as alleged in Schultz v. AngioDynamics, where a LifePort analog fractured undetected for years.
MDL 3125’s 218 cases seek economic damages (e.g., $100,000+ revisions), non-economics for anguish, and punitives for profit-over-safety, echoing Bard’s $48 million PowerPort accord.[9] A Georgia suit by Destiny Kelly claims sepsis from Xcela migration, bolstering design defect patterns across BioFlo kin.[10]
Do I Qualify for a BioFlo Port Lawsuit?
Our Class Action Litigation Group, specializing in implantable device torts, is assessing BioFlo claims nationwide for implanters since 2010 facing fractures, infections, or migrations. Viability demands operative notes, imaging, and revision records tying harms to barium flaws; even surveillance costs qualify under economic loss doctrines. All 50 states welcome filings, with MDL direct access accelerating joinder.
Post-Implant Vigilance and Recall Navigation
Monitor for symptoms via quarterly echoes; explant proactively if cracks appear on fluoroscopy, retaining debris for metallurgy analysis.[11] No recalls mandate returns, but AngioDynamics offers troubleshooting—document refusals for spoliation claims.
Free AngioFlow BioFlo Port Class Action Lawsuit Evaluation
Our attorneys seek patients enduring emboli, sepsis, or surgeries from BioFlo failures—particularly if barium defects are confirmed. With MDL 3125 surging past 200 cases, evidence preservation is urgent. If your BioFlo Port betrayed your trust, contact our firm immediately—compensation awaits via consolidated action, and we’ll champion your cause.
References
- https://www.aboutlawsuits.com/angiodynamics-port-catheter-lawsuit/
- https://www.drugwatch.com/angiodynamics-port/lawsuit/
- https://callfob.com/angiodynamics-port-catheter-lawsuit/
- https://www.torhoermanlaw.com/angiodynamics-port-catheter-lawsuit/
- https://www.peircelaw.com/defective-medical-devices/angiodynamics-port-catheter/
- https://www.aboutlawsuits.com/angiodynamics-port-catheter-lawsuit/angiodynamics-lawsuit-xcela-port-catheter-acute-embolism
- https://www.drugwatch.com/news/2025/09/09/hundreds-sue-angiodynamics-over-port-catheter-injuries/
- https://www.law.cornell.edu/uscode/text/21/360k
- https://www.robertkinglawfirm.com/mass-torts/angiodynamics-port-catheter-lawsuit/
- https://www.medlegal360.com/port-catheter-lawsuit/
- https://ethenostrofflaw.com/angiodynamics-port-catheter-lawsuit/