Cook Medical Sizing Catheters May Fracture, Break, FDA Warns

Concerns over several types of catheters have been raised due to fracture risks, which can cause device fragments to migrate through the bloodstream and lead to serious complications.

The U.S. Food and Drug Administration (FDA) issued a Cook Medical sizing catheter early alert on April 9, indicating the marker bands on some devices may be at risk of cracking or breaking during use.

Sizing catheters are widely used in minimally invasive procedures, particularly during structural heart repairs and device placements, where physicians depend on precise measurements to ensure proper positioning and function.

When these devices fail, the consequences can be serious, as fractured fragments may migrate through the bloodstream or become lodged in blood vessels, increasing the risk of embolization, vascular injury, or the need for additional medical procedures to retrieve fractured components.

The alert highlights a broader pattern of catheter-related safety concerns raised in recent years. Similar fracture and migration issues have been cited in a series of Bard PowerPort and AngioDynamics port catheter lawsuits, which allege that design defects may cause the devices to break and migrate, leading to serious and potentially life-threatening complications, including infections, blood clots and other adverse events.

Cook Sizing Catheter Safety Concerns

The FDA reports that, as of April 2, no injuries or deaths have been linked to the issues with the Cook Medical sizing catheter. However, the agency has not disclosed how many adverse event reports it is currently reviewing, indicating the scope of the problem is still being evaluated.

The early alert announcement signals regulators are actively assessing potential safety risks and may take further action as more information becomes available.

The affected products were distributed nationwide and include:

• Centimeter Sizing Catheters
• Aurous Centimeter Sizing Catheters
• Beacon Tip Centimeter Sizing Catheters

Specific models and lot numbers are identified in the FDA alert.

Regulators advise clinicians to closely monitor these catheters during use for any signs of damage, resistance or unexpected behavior that could indicate a structural failure. If a fracture or separation is suspected, providers should promptly evaluate the patient and take appropriate steps to locate and retrieve any retained fragments, while managing potential complications such as embolization or vascular injury. Patients should also be monitored after procedures for symptoms that may indicate a retained fragment or other adverse effects.

While no specific recommendations have been issued for patients, individuals are advised to contact their health care provider if they experience unusual symptoms following a procedure involving a sizing catheter.

Health care providers are also encouraged to report any adverse events or device malfunctions through the FDA’s MedWatch reporting system.

Catheter Device Failure Lawsuits

In recent years, a substantial number of Bard PowerPort lawsuits and AngioDynamics port catheter lawsuits have been filed against device manufacturers, each alleging that these implantable devices contain defects that create an unreasonable risk of harm to patients. Across these cases, plaintiffs contend that the devices are prone to fracture, migrate or otherwise fail after implantation, increasing the likelihood of serious medical complications.

With respect to Bard PowerPort systems, more than 3,000 lawsuits have been filed nationwide. The claims generally allege that the devices may degrade or break apart within the body, leading to complications such as infection, thrombosis and the embolization of catheter fragments through the bloodstream, which can require urgent medical intervention.

Similarly, hundreds of lawsuits filed against AngioDynamics raise parallel allegations, asserting that certain port catheter models are defectively designed or manufactured. Plaintiffs claim these defects can result in device failure, often necessitating additional treatment, revision procedures or surgical removal.

Given the number of similar claims and shared factual issues, both groups of lawsuits have been consolidated through the federal multidistrict litigation process by the U.S. Judicial Panel on Multidistrict Litigation. Each litigation has been assigned to a separate federal judge for coordinated pretrial proceedings.

As part of this process, the courts are preparing a series of “bellwether” trials. These are representative cases selected to be tried first, allowing both parties to evaluate how juries respond to the evidence and legal arguments presented. While the outcomes of these trials are not binding on other plaintiffs, they often play a critical role in shaping the direction of the litigation, particularly in facilitating settlement discussions.

If no settlement or resolution is reached in either track of port catheter lawsuits, the presiding judge for each set of litigation is expected to begin remanding cases back to their original districts for individual trial dates.

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