Cook Vital-Port Recall Class Action Lawsuit

• Cook Vital-Port Vascular Access Systems – including Titanium Power Injectable Single-Chamber Systems, Standard, Petite and Mini, Titanium and MRI Single-Chamber Systems; devices that could release silicone pieces into the patient’s bloodstream during the implantation procedure and cause medication leakage.

Cook Medical issued a Class II recall in March 2018 (following an initial November 2017 urgent notice) for approximately 31,000 Vital-Port devices. The recall was prompted by reports that a needle provided in the kit could cut a piece of silicone from the port’s septum during the implantation procedure. This silicone piece could then travel into the patient’s bloodstream (embolization), and the port could leak medication, potentially injuring surrounding tissues and preventing adequate delivery of the intended treatment, such as chemotherapy.

Cook Medical voluntarily recalled these products after identifying that the non-coring needle provided with the Cook Vital-Port Vascular Access System may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port [1]. This needle is used on the initial implant of the Vital-Port. No illnesses were reported at the time of the recall announcement. Vital-Port products that have been successfully placed in patients are not impacted by this recall.

Consumers should contact Cook Medical if they have questions about the recall. Cook Medical advised users to inspect stock and quarantine any remaining units of the affected products for return.

Health Risks

• Silicone pieces entering the bloodstream (embolization).
• Insufficient medication delivery to patients.
• Injury to surrounding tissues from medication leakage.
• Complications from inadequate chemotherapy delivery.
• Internal bleeding from silicone migration.
• Damage to organs from traveling silicone fragments.
• Potential need for additional surgical procedures.
• Sepsis and infection from device complications.

Symptoms of a Problem

• Unexpected pain or swelling at the port site.
• Medication not delivering properly.
• Signs of infection around the implantation site.
• Unexplained symptoms related to inadequate treatment delivery.
• Chest pain or difficulty breathing (if silicone reaches heart or lungs).
• Leakage from the port site.
• Device malfunction during medication administration.
• Need for port revision or replacement surgery.

What Consumers Should Do

1. Check if you have a Cook Vital-Port Vascular Access System implanted.
2. Verify the model and serial number of your device with your healthcare provider.
3. Contact your doctor if you experience any complications or symptoms.
4. Keep all medical records related to your port implantation and any complications.
5. Contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235 with questions.
6. Document any adverse events or complications with photos and medical records.
7. If you suffered injuries, seek immediate medical attention.
8. Preserve all documentation related to the device and your treatment.
9. Consider consulting with an attorney about your legal rights.

Potential for a Cook Vital-Port Recall Class Action Lawsuit

Consumers who were injured by Cook Vital-Port devices may join a class action lawsuit. Claims could include:

• The devices were defectively designed with needles that could cut silicone from the septum.
• Silicone pieces embolized and entered patients’ bloodstreams during implantation.
• Medication leaked from the ports, injuring surrounding tissues.
• Patients received inadequate delivery of chemotherapy or other critical treatments.
• Cook Medical failed to adequately test and monitor the device before distribution.
• The company failed to warn patients and healthcare providers about known risks.
• Patients required additional surgeries or medical interventions.
• Internal organ damage occurred from migrating silicone fragments.

You could get compensation for medical expenses, surgery costs, hospitalization, chemotherapy complications, lost wages, pain and suffering, revision surgery expenses, and ongoing medical monitoring. Port-a-cath complications have led to multiple lawsuits claiming that leakage from these devices has resulted in serious injuries requiring extensive treatment.

Implanted Port Complications and Past Lawsuits

Common Port-A-Cath Defects

While Cook’s Vital-Port recall involved specific issues with silicone septum cutting and embolization, implanted ports in general have been associated with various complications:

Material Breakdown: Some implanted ports, like the Vortex Port, have design flaws due to materials that break down over time. Ports made with silicone mixed with barium sulfate can result in the silicone degrading, leading to medication leaking from the device.

Defective Locking Mechanisms: The locking mechanism in these devices is supposed to control the speed at which drugs are administered to patients. Some devices include design flaws allowing medication to leak into the body uncontrolled, which is particularly dangerous with chemotherapy drugs.

Cracking and Breaking: Some devices fracture after being implanted in the patient, resulting in uncontrolled leaking. Additionally, pieces of the device can travel freely through the body, causing internal bleeding and damage to any organs they contact. If broken pieces reach the lungs or heart, there is a significant risk of death.

Port-a-cath complications have led to lawsuits claiming injuries including internal bleeding, constant severe pain, symptoms consistent with a heart attack, tissue and organ perforations, blood clots, necrosis, infection and sepsis, pressure around the heart, and death.

Past Implanted Port Lawsuits

Multiple lawsuits have been filed against manufacturers, doctors, and hospitals for implanted ports. For example, the family of Jesus L. III filed a lawsuit against Texas Children’s Hospital due to his death after having an AngioDynamics Vortex Port implanted in him in 2019. The device malfunctioned within weeks, resulting in broken pieces migrating through his body and chemotherapy chemicals leaking.

Cook Medical’s Extensive Product Liability Litigation

IVC Filter Lawsuits – The Largest Cook Medical Litigation

While the Vital-Port recall affected approximately 31,000 devices, Cook Medical faces far more extensive litigation concerning its inferior vena cava (IVC) filters. As of January 2026, nearly 8,000 lawsuits against Cook are active in a federal multidistrict litigation (MDL 2570) in the Southern District of Indiana before Judge Richard L. Young and Magistrate Judge Tim A. Baker.

The IVC filter lawsuits allege that Cook’s filters, including the Celect and Gunther Tulip models, were defectively designed. The filters were prone to fracture, migrate, or perforate veins and organs. Plaintiffs claim that implanted IVC filters broke apart inside their bodies and caused pieces to travel through their bloodstream, leading to serious injuries including embolization and thrombosis, filter migration, fracture, perforation, sepsis, vessel perforation, cardiac arrhythmia, and death.

Bellwether Trial Results: Unlike competitor C.R. Bard, which settled thousands of IVC filter cases, Cook Medical has generally opted to go to trial. The company won its first bellwether trial in November 2017. However, Cook lost subsequent cases:

• In May 2018, a Texas jury awarded a Houston firefighter $1.2 million after his Cook IVC filter tilted, perforated his aorta and duodenum. The jury found Cook didn’t properly warn the implanting surgeon about the risks.
• In April 2018, an Arizona jury awarded a Georgia woman $3.6 million, including $2 million in punitive damages.
• In February 2019, Tonya Brand was awarded $3 million for injuries from a defective Cook IVC filter that fractured. She was able to pull part of the filter out of her thigh. Though doctors removed most fragments, some remained embedded and will cause complications for the rest of her life. (This verdict was later vacated and a new trial ordered.)

Settlement Discussions: As of October 2025, court documents show that both sides have “reached agreement on the major terms and conditions of settlement” for some cases in the MDL. Settlement conferences took place in late 2025, with parties establishing injury categorization and settlement values for different claim types. However, unlike Bard’s global settlement, Cook has not announced a comprehensive settlement agreement as of January 2026.

Cook Flexor Sheath Lawsuits

Cook Medical also faces ongoing lawsuit investigations related to other devices, including the Cook Flexor Sheath. A recent wrongful death lawsuit was filed in late 2025, alleging that the catheter device malfunctioned during a procedure, leading to a woman’s death.

In November 2020, Cook Medical recalled the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers due to an increased chance of separation at the proximal bond site. The FDA designated this recall as Class I, its most serious level, indicating a reasonable probability the use of the product will cause serious adverse health consequences or death. The recall involved approximately 37,326 devices after at least 57 complaints of catheter separation resulted in at least 14 incidents where patients were seriously injured.

Use of the affected product may cause delays in therapeutic procedures while emergency surgery is performed to retrieve the separated catheter, posing life-threatening adverse events, blocking blood flow to vital organs, vessel injury, and bleeding.

Other Cook Medical Device Recalls and Litigation

Cook Medical has been involved in multiple other device recalls and legal actions:

• Beacon Tip Catheters: Cook conducted recalls in 2015 and 2016 triggered by reports of catheter tips splitting and fracturing. The company removed all Beacon Tip technology catheters from the market and reintroduced them in 2018. In June 2024, Cook reported three serious injuries related to tip separation issues.
• Advance Enforcer Balloon Catheters: Cook recalled these devices in 2019 after reports of the balloons bursting during procedures.
• Zenith Alpha 2 Thoracic Endovascular Grafts: Cook issued a recall due to potential fragmentation that could cause embolization, stroke, and death.

FDA Warning Letter and Quality Management Issues

In 2014, the FDA issued a warning letter to Cook Medical criticizing its quality management system. Inspectors cited the company for failing to establish a verifiable manufacturing process or procedures for investigating nonconforming products. Cook resolved the warning letter in September 2018 after overhauling its quality procedures. The FDA conducted follow-up inspections in 2018 to ensure compliance and found that Cook had adequately addressed all prior violations.

Do I Have a Cook Vital-Port Recall Class Action Lawsuit?

Our law firm handles product liability and medical device defect cases nationwide. We are taking new cases about Cook Vital-Port devices and other implanted port complications.

Free Case Review: If you suffered complications from a Cook Vital-Port device, including silicone embolization, medication leakage, inadequate treatment delivery, or other injuries, contact us today. You may get compensation through a Cook Vital-Port Recall Class Action Lawsuit.

References

1. https://www.rwblawyers.com/practice-areas/implanted-ports
2. https://www.schmidtlaw.com/tivad-lawsuit/
3. https://journals.lww.com/jcejournal/citation/2006/01000/boston_scientific_recall_of_stainless_steel.17.aspx