Cook Medical Angiographic Catheter Recall Issued Following Multiple Reports of Serious Injury: FDA

Manufacturer is aware of reports involving catheter malfunctions, where the tip may separate insude the body, posing a risk of serious vascular injuries.

Federal health officials have announced a recall for certain Cook Medical angiographic catheters after at least three patients were injured by a defect that may cause the catheter tip to detach during use.

The U.S. Food and Drug Administration (FDA) announced the Cook Medical Beacon Tip 5.0 Fr Angiographic Catheter recall on June 25, warning that the tip may separate inside the body during procedures.

Angiographic catheters are thin, flexible tubes inserted into blood vessels to help guide contrast dye during diagnostic imaging procedures, such as angiograms. These devices allow physicians to visualize blood flow in arteries and veins using X-ray or fluoroscopy, helping detect blockages, aneurysms or other vascular abnormalities.

They are commonly used in procedures involving the heart (coronary angiography), brain (cerebral angiography), lungs (pulmonary angiography), and peripheral arteries in the legs or arms. 

However, officials are warning that if the tip detaches, it can lead to serious and potentially life-threatening complications, such as embolism, thrombosis, vessel perforation, sepsis, cardiac arrhythmia or death.

Cook Medical first sent warning letters to customers on May 15, advising them to check their inventory for affected catheters. The letter instructed customers to immediately stop using and quarantine any impacted products.

However, on June 25, the FDA classified the Cook Beacon catheter recall as a Class I recall, the agency’s most serious designation, indicating the product poses a risk of severe injury or death.

While no deaths have been reported in connection with the recall, Cook Medical has received at least three reports of serious injuries involving the angiographic catheters. Tip separations were reported both before and during patient use.

The recalled catheters vary by shaft length, tip curvature, and in some cases, feature a hydrophilic coating designed to ease navigation through blood vessels. A full list of affected models is available in the FDA’s recall notice.

Customers with questions can contact Cook Medical at 800-457-9120 or by email at FieldActionsNA@CookMedical.com. Adverse events or complications related to the Cook Medical Beacon Tip catheter may also be reported through the FDA’s MedWatch Adverse Event Reporting Program.

Fractured Catheter Injuries

The Cook Medical recall comes amid broader safety concerns involving implantable catheter devices. In recent years, both C.R. Bard (a Becton Dickinson subsidiary) and AngioDynamics have faced growing lawsuits over port catheters that allegedly fracture, migrate, or cause severe infections after implantation.

Plaintiffs claim the devices were made with barium sulfate, a radiopaque additive meant to improve visibility on imaging scans. However, the material was allegedly not properly bonded within the catheter’s polymer, causing the device to become brittle and prone to cracking or early degradation.

When fractures occur, catheter fragments can travel through the bloodstream, damaging organs or blocking blood flow. Reported injuries include serious infections, deep vein thrombosis, embolism, organ perforation and cardiac arrhythmia, often requiring emergency surgery or resulting in permanent harm.

Due to the growing number of claims, separate federal multidistrict litigations (MDLs) have been established to coordinate the lawsuits. Bard PowerPort lawsuits have been centralized under MDL No. 3081 in the U.S. District Court for the District of Arizona, where plaintiffs allege that Bard’s implantable port catheters fractured or failed due to material defects, including the improper use of barium sulfate that weakened the device structure.

Similarly, AngioDynamics port catheter lawsuits have been consolidated in MDL No. 3096, pending in the Northern District of New York. These cases raise nearly identical concerns, accusing AngioDynamics of manufacturing port catheters that were prone to cracking, migration, and infection due to poor bonding of radiopaque materials used during production.

Attorneys are currently reviewing port catheter injury lawsuits for individuals who suffered injuries after receiving a Bard or AngioDynamics port catheter. Free consultations and claim evaluations are being offered, with no fees unless compensation is obtained.

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