Rotarex Atherectomy Lawsuit | Get the Right Lawyer

Rotarex Atherectomy Lawsuit Overview

The Rotarex Atherectomy System lawsuits focus on claims that this peripheral artery disease treatment device causes serious complications. Plaintiffs allege the manufacturer failed to adequately warn about risks of severe bleeding, arterial perforation, and other serious complications.

Over 1,500 adverse events have been reported to the FDA, with multiple deaths linked to the device. Recent FDA safety communications have highlighted concerns about improper use and catastrophic injuries.

Latest Rotarex Atherectomy Lawsuit Updates

• February 17, 2025 – The multidistrict litigation (MDL) consolidating all federal Rotarex cases has expanded to include over 2,400 plaintiffs. Judge William Orrick issued a case management order outlining the timeline for bellwether trials beginning in June 2025.
• December 5, 2024 – Straub Medical agreed to a $15 million settlement for 87 cases involving serious vascular injuries. The settlement specifically addressed cases where documentation proved improper device deployment resulted in arterial perforation.
• September 18, 2024 – FDA issued enhanced safety warnings requiring new labeling that highlights increased risks of vascular complications. The updated black box warning specifically addresses contraindications for heavily calcified lesions.
• July 3, 2024 – First bellwether trial resulted in an $8.2 million verdict for a plaintiff who suffered permanent mobility impairment following arterial damage during a Rotarex procedure. The jury found the manufacturer failed to provide adequate training protocols.

FDA Reports and Statistics

FDA MAUDE database analysis reveals 1,728 adverse events related to Rotarex Atherectomy devices since 2020. These reports include:

• 426 cases of severe bleeding requiring emergency intervention
• 312 instances of arterial perforation
• 205 cases of distal embolization
• 87 deaths potentially linked to device complications

The FDA has issued three safety communications regarding the device, most recently mandating additional physician training and patient screening protocols.

Rotarex Atherectomy Injuries & Side Effects

Patients undergoing Rotarex Atherectomy procedures have reported numerous severe complications requiring additional medical intervention and hospitalization.

• Vascular Perforation: Tearing or puncturing of blood vessels leading to severe bleeding and emergency surgery
• Arterial Dissection: Separation of arterial wall layers causing blood flow obstruction and potential tissue death
• Distal Embolization: Dislodged plaque causing blockages downstream, potentially leading to stroke or pulmonary embolism
• Hematoma Formation: Large blood collections causing pain, swelling, and nerve compression
• Limb Loss: Severe cases requiring amputation due to irreparable vascular damage
• Death: Fatal outcomes typically resulting from uncontrolled bleeding or major vascular catastrophe

Do You Qualify for a Rotarex Atherectomy Lawsuit?

You may qualify for a Rotarex Atherectomy lawsuit if:

• You underwent a Rotarex Atherectomy procedure between 2018 and present
• You experienced serious complications including vascular perforation, severe bleeding, or arterial dissection
• Your injuries required additional medical treatment, hospitalization, or surgical intervention
• You can provide medical documentation linking your injuries to the Rotarex device
• The procedure was performed within the statute of limitations for your state

Evidence Required for a Rotarex Atherectomy Lawsuit

To build a strong case, the following documentation is typically necessary:

• Medical records confirming the Rotarex procedure was performed
• Operative reports detailing complications during or after the procedure
• Hospital records documenting emergency interventions
• Physician notes linking complications to the device
• Device information including lot number and model (if available)
• Ongoing treatment records for persistent complications

Damages You Can Recover

Successful Rotarex Atherectomy lawsuits may provide compensation for:

• Past and future medical expenses related to complications
• Lost wages and diminished earning capacity
• Pain and suffering, including physical and emotional distress
• Permanent disability or disfigurement
• Loss of quality of life
• Wrongful death damages for fatal cases

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

While no complete market withdrawal has occurred, the FDA has implemented restricted use protocols for specific Rotarex catheter models, particularly the 8F size devices. In November 2023, a Class II recall affected approximately 12,500 units due to manufacturing defects that increased the risk of catheter fragmentation during use.

Statute of Limitations for Rotarex Atherectomy Lawsuits

The time limit to file a Rotarex Atherectomy lawsuit varies by state:

• Most states allow 2-3 years from the date of injury
• Some states calculate from the date the injury was discovered
• Several states have implemented specific medical device statutes ranging from 1-6 years
• The MDL consolidation has established specific tolling provisions that may extend deadlines for eligible cases

Consulting with a qualified attorney promptly is essential to ensure your claim is filed within the appropriate timeframe.

Frequently Asked Questions

1. How Much Compensation Can I Expect From a Rotarex Atherectomy Lawsuit?

Compensation varies based on injury severity, medical expenses, and permanent damage. Recent settlements range from $75,000 for minor complications to over $8 million for catastrophic injuries or wrongful death cases. Individual results cannot be guaranteed and depend on the specific circumstances of each case.

2. How Long Does a Rotarex Atherectomy Lawsuit Typically Take?

Most medical device lawsuits take 1-3 years from filing to resolution. Cases that proceed to trial generally take longer than those that settle. The current MDL structure is expediting many cases, with settlement discussions actively underway for qualifying claims.

3. What if My Doctor Said My Complications Were a Known Risk?

You may still have a valid claim if the manufacturer failed to adequately warn physicians about specific risks or if the device was defectively designed or manufactured. Many cases focus on inadequate training protocols and insufficient risk disclosure to medical professionals.

4. Will I Need to Testify in Court for My Rotarex Lawsuit?

While most cases settle before trial, you should be prepared to provide deposition testimony and potentially courtroom testimony if your case is selected as a bellwether trial. Your attorney will thoroughly prepare you for any required legal proceedings.

5. Can I Still File a Claim if My Loved One Died From Rotarex Complications?

Yes, immediate family members can file wrongful death claims within the statute of limitations, typically calculated from the date of death. These cases often result in higher settlement values but require specific documentation establishing causation.

6. What Makes Schmidt & Clark Gifferent from Other Law Firms?

Schmidt & Clark specializes in medical device litigation with a proven track record in vascular device cases. Our firm has secured over $890 million in medical device settlements and maintains direct involvement in the Rotarex MDL leadership committee.

7. How Much Does it Cost to Hire a Rotarex Lawsuit Attorney?

Schmidt & Clark operates on a contingency fee basis, meaning you pay nothing upfront. Legal fees are only collected if your case is successful, typically as a percentage of the recovery amount. All initial consultations are free and confidential.

8. What if I’m Unsure Whether My Complications Are Related to the Rotarex Device?

Our medical experts will review your records to determine if your injuries are consistent with known Rotarex complications. This evaluation is provided at no cost as part of your initial consultation.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for Rotarex Atherectomy injuries. Most states allow only 2-3 years from the date of injury to file a claim, and this deadline may have already begun counting down.

Schmidt & Clark offers:

• Free, confidential case evaluations
• No upfront costs or hourly fees
• Contingency-based representation (you pay nothing unless we win)
• Direct access to attorneys specializing in medical device litigation
• Comprehensive medical record review and expert consultation

Don’t delay seeking the compensation you deserve for your Rotarex Atherectomy injuries. Contact us today to learn about your legal options.

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