Rotarex Atherectomy Lawsuit | 2025 Latest Updates

Rotarex Atherectomy Lawsuit Overview

The Rotarex Atherectomy lawsuits focus on claims that the device’s rotating helix component can fracture or break inside patients’ bodies during procedures.

These lawsuits allege that Bard Peripheral Vascular (BD) failed to adequately test the device and warn about potential risks.

The FDA has linked the device to at least 4 deaths and 30 serious injuries, with 115 additional cases requiring medical intervention due to device failure [1].

Latest Rotarex Atherectomy Lawsuit Updates

• February 10, 2025 – BD (Becton, Dickinson and Company) publicly warned about severe risks linked to its Rotarex Atherectomy catheters, following reports of four deaths and over 30 serious injuries. The company issued updated usage instructions (eIFU) and corrective actions to healthcare providers to mitigate device failure risks [2].
• February 6, 2025 – The FDA issued an early alert concerning the Rotarex Atherectomy System, highlighting severe safety concerns after reports of multiple deaths and injuries linked to the device’s rotating helix component fracturing inside patients.
• February 5, 2025 – BD (manufacturer) issued a Medical Device Correction letter to affected customers, providing updated instructions for use (eIFU) and recommended that healthcare providers review these instructions thoroughly.
• February 2025 – Legal firms including Schmidt & Clark, LLP began accepting Rotarex Atherectomy lawsuits nationwide as reports of serious complications continued to emerge.

FDA Reports and Statistics

According to FDA reports, the Rotarex Atherectomy System has been associated with:

• 4 confirmed deaths linked to device failure
• 30 serious injuries requiring significant medical intervention
• 115 additional cases requiring medical intervention following helix fracture or breakage
• Multiple adverse event reports submitted to the FDA’s MedWatch Safety Information program

The FDA alert specifically noted that the device’s rotating helix component is prone to fracturing under certain conditions, including stress, wear, high temperatures, friction, or localized pressure.

Rotarex Atherectomy Injuries & Side Effects

Patients who have undergone procedures with the Rotarex Atherectomy System have reported a range of serious injuries and complications.

• Vessel Injury: Perforation or damage to blood vessels during or after the procedure
• Severe Bleeding: Internal hemorrhaging requiring emergency intervention
• Embolism: Device fragments traveling through the bloodstream causing blockages
• Emergency Surgery: Procedures required to remove broken device fragments
• Death: Fatal complications in the most severe cases

Do You Qualify for a Rotarex Atherectomy Lawsuit?

You may qualify for a Rotarex Atherectomy lawsuit if:

• You underwent a procedure using the Rotarex Atherectomy System
• You experienced serious complications including vessel injury, severe bleeding, or required additional surgical intervention
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the Rotarex device

Evidence Required for a Rotarex Atherectomy Lawsuit

To build a strong case, you will need to provide:

• Medical records documenting the use of a Rotarex Atherectomy device
• Documentation of complications or injuries following the procedure
• Treatment records for any subsequent interventions
• Documentation of ongoing medical care related to the complications

Damages You Can Recover

Successful Rotarex Atherectomy lawsuits may allow you to recover compensation for:

• Medical expenses, including emergency interventions and ongoing care
• Lost wages and diminished earning capacity
• Pain and suffering related to complications
• Punitive damages against the manufacturer in cases of gross negligence

Check out our website to find out which medical device lawsuits our lawyers are currently accepting

Related Article: Atherectomy Amputation Lawsuit

Rotarex Atherectomy Recall Information

As of March 2025, the FDA has issued an early alert about the Rotarex Atherectomy System but has not yet mandated a full recall.

BD has implemented a Medical Device Correction, updating the instructions for use and offering additional training to healthcare providers.

The situation remains fluid, and further regulatory actions may follow based on ongoing investigations.

Statute of Limitations for Rotarex Atherectomy Lawsuits

The time limit to file a Rotarex Atherectomy lawsuit varies by state but typically ranges from 1-3 years from the date of injury or the date you discovered the connection between your injury and the device.

Due to these varying deadlines, it’s crucial to consult with an attorney as soon as possible to protect your legal rights.

FAQs

1. How do I know if my complications are related to the Rotarex Atherectomy device?

If you experienced unusual complications following your procedure, such as excessive bleeding, emergency interventions, or were informed about device fragments, these could indicate Rotarex-related issues. Your medical records and consultation with your physician can help determine if your injuries are linked to the device.

2. What compensation can I expect from a Rotarex Atherectomy lawsuit?

Compensation varies based on the severity of injuries, medical expenses, lost wages, and other damages. Cases involving permanent disability or death typically result in higher settlements. Your attorney can provide a more specific estimate after reviewing your case details.

3. How long does a Rotarex Atherectomy lawsuit take?

The time frame varies, but most medical device lawsuits take between 1-3 years to resolve. Factors affecting timeline include case complexity, the number of plaintiffs involved, and whether the case settles or goes to trial.

4. Is this a class action lawsuit?

Currently, Rotarex Atherectomy cases are being handled as individual lawsuits rather than class actions, allowing each plaintiff to seek compensation based on their specific injuries and circumstances.

5. Do I need medical records to file a Rotarex Atherectomy lawsuit?

Yes, medical documentation is crucial to establish that the Rotarex device was used and to demonstrate the link between the device and your injuries. Your attorney can help gather these records.

6. What is the Rotarex Atherectomy System used for?

The device is used to treat Peripheral Arterial Disease (PAD) by removing plaque and thrombotic material from arterial walls using a rotating helix mechanism that both cuts and removes the material.

7. Will I have to testify in court?

While most cases settle before trial, you should be prepared for the possibility of providing testimony. Your attorney will thoroughly prepare you if this becomes necessary.

8. How does BD’s Medical Device Correction impact my case?

The correction acknowledges issues with the device, which may strengthen your case by providing evidence that the manufacturer was aware of potential problems. However, it does not automatically establish liability.

Get A Free Rotarex Atherectomy Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Rotarex Atherectomy injuries. In many states, you have only 2 years from the date of injury to file your claim. Waiting too long could permanently forfeit your right to compensation.

Our legal team at Schmidt & Clark, LLP offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or legal fees
• Payment only if we win your case
• Nationwide representation with attorneys experienced in medical device litigation

Don’t wait until it’s too late to seek justice and compensation for your suffering.

References: 

1. https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular
2. https://www.massdevice.com/bd-warns-atherectomy-catheters-deaths/