Texas Rotarex Atherectomy System Lawyer

The Rotarex Atherectomy System has been linked to 4 deaths and 30 serious injuries when the helix portion of the device fractured or broke off inside a patient’s body.

Need a Texas Rotarex Atherectomy System Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were injured when a Rotarex Atherectomy System fractured or broke, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

What is the Rotarex Used For?

The Rotarex® Atherectomy System is a medical device that is used to clear arteries by breaking up and removing fatty plaque deposits or blood clots, which helps improve blood-flow to the arms and legs.

How Does It Work?

The Rotarex Atherectomy System is used in an artery-clearing medical procedure called an atherectomy.

During an atherectomy, a thin flexible tube called a catheter is inserted into the patient’s artery. At the tip of the catheter is a Rotarex Atherectomy System, which is a device that has a high-speed spinning corkscrew (called a “helix”) that is designed to break up and suck out the fatty plaques or blood clots.

Rotarex Atherectomy System Linked to 4 Deaths

In February 2025, the FDA published an Early Alert after 4 deaths were linked to the Rotarex Atherectomy System when the high-speed spinning helix portion of the device fractured and/or broke off. According to the FDA:

“BD has reported 30 serious injuries and 4 deaths associated with this issue. Additionally, BD has reported 115 cases requiring additional intervention following helix fracture and/or breakage.”

What is the Problem?

The helix portion of the Rotarex Atherectomy System can fracture and/ or break inside a patient’s body. This is a life-threatening emergency.

If the helix fractures or breaks, it “could cause vessel injury and may lead to severe bleeding or death,” according to the FDA. Patients must also undergo “retrieval of a broken catheter and/or device fragment.”

Patients May Need Emergency Medical Procedures

If the Rotarex Atherectomy System breaks, patients may need emergency surgery or additional medical procedures to stop severe internal bleeding, repair broken blood vessels, retrieve the broken catheter or fragment of the Rotarex device, and treat complications.

Atherectomy Lawsuits

A growing number of atherectomy lawsuits have been filed by people needed leg amputations when the procedure went horribly wrong.

Instead of saving their legs, these victims were left disfigured and disabled by atherectomy procedures. Many patients were told they needed to have an atherectomy to prevent the loss of their legs — but instead, they lost their legs due to an atherectomy that was not even medically necessary.

$5 Million Settlement in Atherectomy Lawsuits

In one atherectomy lawsuit, a doctor in North Carolina paid a $5 million settlement to resolve claims that he falsely billed Medicare and Medicaid for “millions” of dollars for “unnecessary atherectomy procedures to remove minor plaque blockage in leg arteries,” according to the Justice Department.

Need a Rotarex Atherectomy System Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.