About the Bard Atherectomy Catheter Lawsuit Investigation
The Bard Atherectomy Catheter lawsuit investigation focuses on a dangerous pattern of device failures tied to serious vascular injuries and patient deaths.
The Rotarex Atherectomy Catheter is a mechanical thrombectomy device used by physicians to remove occlusions from native peripheral arteries or artificial bypasses, typically in the lower limbs.
It is intended for use in carefully controlled, image-guided settings, where the rotating catheter shaft helps dislodge and extract arterial blockages.
However, reports submitted to the FDA revealed that the catheter shaft and inner helix component can fracture or break during use—often inside fragile blood vessels.
These failures have led to severe complications, including embolization, severe bleeding, emergency surgery, and at least four patient deaths.
In many cases, broken fragments had to be surgically retrieved from within the artery, presenting extreme danger and delay in treatment.
The investigation is examining whether Bard failed to adequately warn healthcare providers of these risks or correct known safety issues in time.
If you or a loved one experienced severe complications such as internal bleeding, vessel damage, or required emergency surgery after a procedure involving the Bard Atherectomy Catheter, you may be eligible to pursue compensation.
Contact us for a free consultation.
Bard Peripheral Vascular Recall Overview
Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Company, issued a recall of several Rotarex Atherectomy Systems due to an urgent atherectomy catheter system issue.
The recall was prompted by serious safety concerns involving the structural integrity of the catheter’s rotating inner component—known as the helix portion.
The FDA classified the action as a Class I recall, the most critical level, due to the risk of life-threatening injuries or death.
The primary failure mode involves helix fracture, where the rotating part of the device breaks during use, potentially resulting in damage to the arterial wall, internal bleeding, or embolic events.
The recalled devices are used to remove occlusive material in native peripheral arteries and bypass grafts.
According to post-market surveillance and adverse event reports, fractures may occur when the device is not kept in constant catheter movement, or when used in tortuous vessels such as near a vessel bifurcation.
Improper technique or anatomical challenges can also contribute to catheter overheating, which further increases the likelihood of structural failure.
Bard’s recall included a Medical Device Correction Letter that outlined revised safety instructions aimed at reducing procedural risks and improving medical device safety.
The correction letter emphasized key handling precautions, such as:
- Always keeping the catheter in motion to avoid undue stress on the helix portion
- Avoiding use in sharply curved or bifurcated vessels
- Employing reinforced sheaths to minimize flexion and bending
- Monitoring for signs of resistance or adverse reactions during the procedure
Despite these changes, serious injuries—including vascular damage and deaths—have continued to surface, raising questions about the device’s design, risk communication, and continued use in peripheral artery interventions.
Complications and Injuries Linked to Bard Atherectomy Catheter Devices
Complications linked to the Bard Atherectomy Catheter appear to stem from structural failures within the device during use in delicate arterial environments.
The catheter’s rotating helix, designed to remove arterial plaque and thrombus, can fracture or break off inside the vessel.
This may occur when the device is subjected to stress, particularly if used without a suitably reinforced sheath or in sharply curved vessels.
When fragments break free, they can damage vessel walls, cause downstream blockages, or lead to uncontrolled internal bleeding.
In some cases, broken components must be surgically removed, prolonging procedure time and increasing the risk of further injury.
These dangerous outcomes have been reported in both routine and emergency vascular procedures.
Common complications linked to the Bard Atherectomy Catheter include:
- Fracture or breakage of the catheter shaft or internal helix
- Vessel wall injury or perforation
- Life-threatening internal or severe bleeding
- Embolism or downstream blockage from device fragments
- Emergency surgery to retrieve broken parts or repair damaged arteries
- Death due to uncontrolled bleeding or vascular trauma
How Could These Injuries Have Been Prevented?
Many of the injuries linked to the Bard Rotarex Atherectomy Catheter may have been preventable with earlier intervention, clearer warnings, and design modifications.
Reports submitted to the FDA suggest that a significant number of complications—such as vessel injury, internal bleeding, and the need for emergency surgery—were caused by a broken catheter during use.
These breakages often occurred due to stress on the device during catheter advancement, especially in complex or curved arterial pathways.
While Bard eventually issued a recall and updated usage guidelines, questions remain about whether the company acted quickly enough to protect patients.
Several catheter advancement related factors and certain procedural factors appear to have contributed to device failure.
For example, advancing the catheter through a vessel with sharp bends or narrowing may increase pressure on the internal helix, heightening the risk of fracture.
Failure to maintain adequate blood flow or monitor for resistance during use also played a role in several adverse events.
Had these risks been more clearly communicated through timely medical device recalls or proactive physician education, some of the most serious injuries and deaths might have been avoided.
A lawsuit investigation will likely focus on whether Bard failed to implement safeguards or issue warnings when early signs of danger became apparent.
Current Lawsuits Against Bard Peripheral Vascular
The legal investigation into the Bard Atherectomy Catheter comes at a time when Bard Peripheral Vascular is already facing significant scrutiny in other product liability cases.
The company, a subsidiary of Becton, Dickinson and Company (BD), is currently the target of ongoing Bard PowerPort lawsuits filed by patients nationwide.
These lawsuits allege that the defective Bard PowerPort device, an implantable port catheter used for long-term vascular access, can fracture, migrate, or cause infections, leading to serious complications.
Plaintiffs claim that Bard failed to properly test the device or warn healthcare providers about its risks—allegations that mirror growing concerns about Bard’s oversight of its other medical products.
Bard Peripheral Vascular, Inc. was formerly part of C.R. Bard, Inc., which was acquired by BD in 2017.
BD continued to operate Bard’s vascular and interventional product lines, including the PowerPort and the Rotarex Atherectomy System, under the Bard brand.
Now, both the Bard PowerPort litigation and the new investigation into the atherectomy catheter system raise questions about the company’s overall commitment to medical device safety.
In both cases, device failures have been linked to serious patient injuries and deaths.
As the catheter lawsuit investigation progresses, lawyers are likely to examine whether the company’s corporate response to known risks followed the same patterns seen in the PowerPort cases.
The emerging litigation may signal broader systemic issues within the company’s product design, testing, and post-market safety protocols.
Do You Qualify for a Rotarex Atherectomy System Lawsuit?
You may qualify for a Rotarex Atherectomy System lawsuit if you or a loved one suffered serious complications during a procedure involving the device.
Common qualifying injuries include severe bleeding, vessel damage, emergency surgery, or death caused by a fractured or malfunctioning catheter.
The device’s rotating helix, which is intended to break up blockages in narrowed arteries, has been reported to fracture during use, releasing metal fragments inside the blood vessels.
These broken pieces can puncture arterial walls, block blood flow, or migrate to other areas of the body, causing extensive damage.
Lawsuits are being evaluated for individuals who underwent vascular procedures for peripheral artery disease (PAD) and experienced sudden complications related to the catheter.
Many of these procedures involved unnecessary or overly aggressive use of atherectomy systems, increasing the likelihood of harm.
Patients who required additional surgeries to retrieve device fragments or who suffered permanent vascular damage may be eligible to file a claim.
Claims may also be considered in cases of wrongful death following a failed procedure using the Rotarex system.
Legal investigations are examining whether Bard Peripheral Vascular failed to adequately warn physicians of the risks or provide sufficient safety guidance.
If your injury occurred during a procedure involving this device, you may have a valid case.
TorHoerman Law: Investigating Potential Bard Atherectomy Catheter Lawsuits
TorHoerman Law is actively investigating claims related to injuries and deaths caused by the Bard Rotarex Atherectomy Catheter.
Our legal team is reviewing cases involving device malfunctions that led to severe bleeding, vessel injury, emergency interventions, or loss of life.
We are committed to helping individuals and families understand their legal rights and pursue the compensation they may be owed.
If you or a loved one experienced complications during a procedure involving a Bard atherectomy catheter, you may be eligible to file a claim.
Our firm has extensive experience in defective medical device litigation and will handle your case with the compassion, focus, and determination it deserves.
