Rotarex Atherectomy System Lawsuit

The Rotarex Atherectomy System is an artery-clearing device that can fracture or break, which is linked to 4 deaths and at least 30 serious injuries.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Rotarex Atherectomy System induced injury cases in all 50 states. If you or somebody you know was injured when a Rotarex Atherectomy System helix fractured and/or broke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Rotarex Atherectomy System Linked to 4 Deaths, 30 Serious Injuries

In February 2025, the FDA issued an Early Alert for the Rotarex Atherectomy System, after 4 people died when the high-speed spinning tip of the device (called the “helix”) fractured or broke off.

The FDA explained that it was warning about a “potentially high-risk device issue” for Rotarex Atherectomy Systems that were manufactured by Bard Peripheral Vascular, which is a subsidiary of the medical company BD.

How Many People Were Injured or Died?

BD reported “30 serious injuries and 4 deaths” and 115 reports that a Rotarex Atherectomy helix fractured or broke, 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 Helix?

The helix is a part of the Rotarex Atherectomy System that spins very fast to break up and remove blood clots from narrowed arteries.

The device is used in patients with Peripheral Artery Disease (PAD), a condition in which narrowed arteries reduce blood-flow to the arms or legs. It is often caused by a collection of plaque, fat and cholesterol that lines the artery walls. This is called atherosclerosis.

What is the Problem?

The helix portion of the Rotarex Atherectomy System can potentially break or fracture, which is a life-threatening or deadly complication.

The broken helix will will require “retrieval of a broken catheter and/or device fragment. A helix fracture or break could cause vessel injury and may lead to severe bleeding or death,” according to the FDA.

BD Warns Doctors About Risk of Rotarex Helix Fracture and/or Breaks

On February 5, 2025, BD sent out a Medical Device Correction letter to warn doctors about certain patient characteristics that “could contribute to helix fracture and/or breakage events.”

The FDA warned that “The helix portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure.”

Use of the device in certain anatomy and lesion types, as well as certain procedural factors, may cause the helix to fracture or break, requiring retrieval of a broken catheter and/or device fragment.

Atherectomy Lawsuits For Amputations & Serious Injuries

A growing number of atherectomy lawsuits have been filed by people who were seriously injured. These lawsuits claim that doctors aggressively marketed these artery-clearing procedures, without warning patients about the risks.

The profit-driven rise in atherectomy procedures has resulted in skyrocketing profits for doctors and medical device companies — and a tragic number of amputations, serious injuries, and even deaths.

Do I Really Need an Atherectomy?

Atherectomies are invasive, high-risk, and often unnecessary for patients with mild artery disease — especially if they only have mild symptoms that do not significantly decrease quality of life.

Lawsuits claim that profit-driven doctors are actually harming patients by telling patients they need to have an artery-clearing procedure to save their legs. Instead, patients have suffered injuries that led to amputations.

In one horrific case, at least 45 patients needed amputations after undergoing artery-clearing atherectomy procedures by Dr. Jihad Mustapha, a doctor from Michigan who is now facing several lawsuits.

In another case, Dr. Hari Saini, a cardiologist from North Carolina, paid a $5 million settlement to resolve claims that he “performed unnecessary atherectomy procedures to remove minor plaque blockage in leg arteries” and billed it to Medicare and Medicaid. Based upon billing records, he was paid “millions” of dollars.

“Physicians cannot perform procedures on patients who don’t need them just to make more money,” said Attorney General Josh Stein. “That’s a waste of taxpayer resources and a fundamental abuse of the trust we put in doctors.”

Should I File a Lawsuit?

Lawsuits have been filed by people who were seriously injured by artery-clearing atherectomy procedures. These lawsuits involve malpractice from doctors who performed unnecessary procedures.

Atherectomy lawsuits may also be filed against medical device companies who profited and sold devices that harmed patients.

If you were injured by the Rotarex Atherectomy System, you are not alone. Our lawyers may be able to help you (or your family member) seek justice and compensation for your injuries or wrongful deaths.

Do I Have a Rotarex Atherectomy System Lawsuit?

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