Published by If you received a Cook Vital-Port device and later experienced device malfunction, leakage, embolization concerns, or treatment complications, you may be eligible for legal review through a Cook Vital-Port Recall Lawsuit.
Our legal team offers a free, no-obligation consultation and accepts representation on a contingency-fee basis.
Table Of Contents
- What’s the Problem?
- Latest Updates
- Product & Usage Overview
- Recall Details
- Potential Injuries and Complications
- Cook Medical and Related Device Litigation
- Do You Qualify for a Cook Vital-Port Recall Lawsuit?
- Legal Theories & Liability Grounds
- Statute of Limitations & Timing
- Why You Should Act Now
- References
What’s the Problem?
The Cook Vital-Port Vascular Access System is an implanted port designed to provide repeated vascular access for administering medications such as chemotherapy. Safety concerns arose when reports indicated that a needle provided with the system could cut or shear a piece of silicone from the port’s septum during implantation.
If released, silicone fragments could enter the bloodstream, creating a risk of embolization. The damage to the septum could also cause medication leakage into surrounding tissue and interfere with proper drug delivery.
Latest Updates
- March 2018 – Cook Medical issued a Class II recall covering approximately 31,000 Vital-Port devices following reports that a needle used during implantation could cut silicone from the port septum, creating risks of embolization and medication leakage. [1]
Product & Usage Overview
The Vital-Port Vascular Access System is a type of totally implantable venous access device (TIVAD). These devices are surgically implanted beneath the skin and connected to a catheter inserted into a vein, allowing repeated access for infusion therapies without repeated needle sticks.
The recalled Vital-Port systems included a specific needle design that, under certain conditions, could damage the silicone septum during implantation.
Recall Details
The recall followed an earlier urgent notice issued in November 2017 and was formally classified in March 2018. Approximately 31,000 devices were affected. At the time of the recall announcement, no patient injuries had been reported.
The recall addressed both the risk of silicone embolization and the potential for medication leakage, which could reduce treatment effectiveness and injure surrounding tissue.
Potential Injuries and Complications
Although no injuries were reported when the recall was announced, the identified failure modes can present serious medical risks. Potential complications associated with implanted port failures may include:
- Silicone embolization into the bloodstream
- Local tissue injury from leaked medication
- Inadequate delivery of chemotherapy or other critical drugs
- Need for additional procedures to remove or replace the port
- Infection or vascular complications related to device malfunction
Cook Medical has faced extensive product liability litigation involving other implantable vascular devices. The most prominent cases involve inferior vena cava (IVC) filters, including the Celect and Tulip models, which were alleged to fracture, migrate, or perforate veins and organs.
Thousands of IVC filter lawsuits have been consolidated into federal multidistrict litigation in the Southern District of Indiana. As of early 2026, nearly 8,000 cases remained active, with mixed trial outcomes including verdicts exceeding one million dollars for some plaintiffs.
Additional lawsuits and investigations involving other Cook Medical devices, including catheter and sheath systems, have also been filed, including wrongful death claims alleging device malfunction during medical procedures.
Do You Qualify for a Cook Vital-Port Recall Lawsuit?
You may qualify to pursue a Cook Vital-Port Recall Lawsuit or related claim if one or more of the following apply:
- You received a Cook Vital-Port Vascular Access System that was subject to the recall.
- You experienced complications consistent with device malfunction, leakage, or embolization concerns.
- You required additional medical procedures, port replacement, or suffered treatment disruption.
- You have medical records identifying the implanted device and documenting the complications.
Evidence You Should Gather
- Implantation records identifying the Vital-Port system and lot number.
- Operative reports and follow-up medical records.
- Imaging or diagnostic reports addressing port function or complications.
- Records of additional procedures or port removal.
- Billing statements and documentation of related medical expenses.
Damages You Can Recover
Available damages depend on state law and case-specific facts, but may include:
- Medical expenses: implantation complications, corrective procedures, and follow-up care.
- Lost wages: time missed from work due to treatment or recovery.
- Pain and suffering: physical discomfort and emotional distress.
- Out-of-pocket costs: transportation, caregiving, and related expenses.
Legal Theories & Liability Grounds
Vital-Port claims may be evaluated under product liability theories such as:
- Design defect: allegations that the needle-port interaction created an unreasonable risk of septum damage.
- Failure to warn: allegations that risks associated with the implantation process were not adequately disclosed.
- Negligence: allegations involving product testing, quality control, and risk mitigation.
Statute of Limitations & Timing
Deadlines for filing medical device injury claims vary by state and may depend on when complications were discovered. Preserving medical records and device documentation early can be critical to evaluating potential claims.
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Why You Should Act Now
Implanted port complications can disrupt life-saving treatment and lead to additional medical procedures. If you received a recalled Cook Vital-Port device and experienced complications, a legal review can help determine whether a Cook Vital-Port Recall Lawsuit is appropriate and what documentation is needed to protect your rights.
References
- https://www.schmidtlaw.com/tivad-lawsuit/