Cook Medical Angiographic Catheter Recall

At KBD Attorneys, we regularly investigate product recalls involving medical devices, especially when those products place patients at risk of severe or life-threatening injuries. On June 25, 2025, the U.S. Food and Drug Administration (FDA) issued a Class I recall—its most serious designation—for the Cook Medical Beacon Tip 5.0 Fr Angiographic Catheter. This action comes after multiple reports of serious injury linked to a dangerous defect: the catheter’s tip may detach inside the body during use, resulting in devastating complications.

If you or a loved one has undergone an angiographic procedure in recent months and suffered unexpected complications, you could be entitled to legal action. Here’s what you need to know.

What Is an Angiographic Catheter?

Angiographic catheters are thin, flexible tubes used to guide contrast dye during diagnostic imaging procedures. An angiogram is an example of this type of procedure. These procedures allow doctors to evaluate blood flow through arteries and veins and help detect:

• Blocked vessels

• Aneurysms

• Congenital abnormalities

• Vascular malformations

Angiographic catheters are commonly used in coronary, cerebral, pulmonary, and peripheral angiography, meaning they can be threaded through blood vessels in the heart, brain, lungs, or limbs. Given their critical role in these high-stakes procedures, any device failure can have immediate and catastrophic consequences.

Why Was the Cook Catheter Recalled?

The FDA recall was triggered after at least three patients suffered serious injuries when the tip of the Cook Medical Beacon Tip catheter separated inside the body. This type of failure can lead to:

• Embolism

• Thrombosis (blood clots)

• Vessel perforation

• Sepsis

• Organ damage

• Cardiac arrhythmia

• Death

According to AboutLawsuits.com, Cook Medical first notified customers about the risk in May 2025, asking them to stop using the affected products. But the situation escalated, and by June 25, the FDA issued a Class I recall—the highest level of recall reserved for products that pose a risk of serious injury or death.

The affected catheters vary by shaft length, tip curvature, and include models with hydrophilic coatings, which are designed to aid smooth navigation through blood vessels.

Cook Medical’s History of Safety Concerns

Cook Medical has faced scrutiny before for product-related injuries, but this recall is part of a broader pattern involving implantable catheter devices. Manufacturers like Becton Dickinson (Bard) and AngioDynamics are already facing lawsuits over port catheters that allegedly fracture, migrate, or cause life-threatening infections.

In these lawsuits, plaintiffs argue that companies used barium sulfate, a radiopaque additive designed to enhance imaging visibility, but failed to bond it properly to the catheter’s polymer material. This resulted in weakened devices prone to cracking, fracturing, and early failure.

Similar outcomes may be possible with the Cook Beacon Tip catheter, especially since fragments from a separated catheter tip could travel through the bloodstream and damage vital organs.

Legal Action and Current Litigation

The Cook catheter recall has not yet resulted in multidistrict litigation (MDL), but two major MDLs involving similar catheter devices are already underway:

• Bard PowerPort Lawsuits (MDL No. 3081) – Centralized in the U.S. District Court for the District of Arizona, this MDL involves claims that Bard’s implantable catheters fractured or failed due to barium sulfate degradation.

• AngioDynamics Port Catheter Lawsuits (MDL No. 3096) – Centralized in the Northern District of New York, these cases raise nearly identical concerns, including design defects and life-altering injuries.

Given the severity of injuries linked to the Cook catheter recall, legal experts anticipate additional product liability lawsuits may soon follow. At KBD Attorneys, our product liability team is already reviewing potential claims related to the Cook Medical recall and offers free case evaluations to individuals who have suffered after using the affected product.

Signs You May Have Been Affected

If you recently underwent an angiogram or catheterization procedure, especially one involving Cook Medical products, be alert to the following symptoms:

• Sudden chest pain or shortness of breath

• Unexplained infection or fever

• Numbness or discoloration in limbs

• Arrhythmias or abnormal heart rhythms

• Organ failure or persistent fatigue

Any of these symptoms may indicate a vascular injury, blood clot, or infection caused by a detached catheter tip. These situations can quickly become medical emergencies, so it’s important to seek care immediately.

Additionally, patients who experienced complications but were unaware of the device brand used in their procedure can request their medical records or consult with a product liability attorney to determine their next steps.

What Should You Do if You’ve Been Harmed?

If you or a loved one experienced complications following a diagnostic procedure involving a catheter, you may be eligible for:

• Compensation for medical bills and future care

• Pain and suffering

• Lost income or reduced earning capacity

• Wrongful death claims (for surviving families)

KBD Attorneys is investigating potential lawsuits on behalf of individuals injured by the Cook Medical Beacon Tip 5.0 Fr Angiographic Catheter. If you were hospitalized, underwent emergency surgery, or suffered complications following an angiography or catheter-related procedure, you may have a legal case.

We have written about the Bard Powerport if you would like to read more on this issue.

How KBD Attorneys Can Help

Our attorneys have deep experience handling medical device injury lawsuits, including catheter defects, surgical mesh failures, and defective implants. We understand how to:

• Investigate product recalls

• Work with medical experts to link your injury to a specific device

• Hold manufacturers accountable

• Fight for fair settlements or take your case to trial

We operate on a contingency fee basis, meaning you pay nothing unless we win compensation for you.

Final Thoughts: Accountability and Patient Safety

Medical devices are supposed to help—not harm—patients. But when companies release defective products or fail to notify patients and physicians in a timely manner, lives are put at risk. The Cook Medical catheter recall is just one example of what can go wrong when profit is prioritized over patient safety.

The FDA’s Class I designation sends a clear message: this product is dangerous, and patients deserve answers.

Contact KBD Attorneys Today

If you believe you’ve been affected by the Cook Medical angiographic catheter recall or a similar catheter-related injury, contact KBD Attorneys for a free and confidential consultation.

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