Baltimore HeartMate Recall Lawyer

HeartMate recall representation on a contingency basis. No attorney fees unless we recover compensation for you.

If you or a loved one was implanted with a HeartMate II or HeartMate 3 left ventricular assist device and experienced a stroke, device failure, emergency surgery, or death, the manufacturer may be liable for the harm caused. These devices have been the subject of multiple FDA recalls, and patients and families are left dealing with the consequences.

KBD Attorneys is actively pursuing claims against the makers of the HeartMate system. Our Baltimore, MD HeartMate recall lawyer has been at the forefront of medical device litigation for decades, and we bring that same depth of knowledge to these cases. Consultations are free, and we charge no fee unless we recover for you. Contact us to discuss your case.

HeartMate Recall Lawyer Baltimore, MD

What are the HeartMate devices, and why are they being recalled?

The HeartMate II and HeartMate 3 are left ventricular assist devices, or LVADs, manufactured by Abbott (formerly Thoratec/St. Jude Medical). They are implanted in patients with severe heart failure to help pump blood from the left ventricle to the rest of the body. A HeartMate recall attorney in Baltimore understands the specific mechanical and design problems with these devices that have led to multiple FDA recalls.

The core problem involves the device’s rigid elbow design coupled with its DACRON graft, which is porous. Biological matter like plasma and other substances becomes trapped between the graft and the rigid elbow, gradually choking off the blood supply. This can lead to strokes, thrombosis, device failure, emergency interventions, and death.

Types of HeartMate Injuries We Handle in Baltimore

Our firm represents patients and families in Baltimore, MD and nationwide who have been harmed by the HeartMate II and HeartMate 3 devices. The injuries these devices cause are severe and often life-threatening.

• Stroke. When the device’s design causes blood flow obstruction or thrombosis, the risk of ischemic stroke increases significantly. Stroke can result in permanent brain damage, loss of speech, paralysis, and death.
• Device thrombosis. Blood clots forming within or around the device can obstruct blood flow and cause pump malfunction, requiring emergency intervention or device replacement surgery.
• Pump failure. Mechanical failure of the HeartMate device leaves patients without circulatory support, creating a medical emergency that can be fatal.
• Controller malfunctions. The device’s external controller has also been subject to recalls for malfunctions that can interrupt power to the pump. Loss of power to an LVAD can cause death within minutes.
• Infection from the device. Implanted devices carry infection risks, and the HeartMate system’s design has been associated with driveline infections that can become systemic.
• Emergency revision surgery. When a HeartMate device fails, patients face high-risk open-heart surgery to replace or remove the device. These surgeries carry significant morbidity and mortality.
• Death. The most serious HeartMate recalls have been linked to patient deaths. Families who have lost a loved one to a HeartMate device failure may have wrongful death claims.
• Power cord failures. Additional recalls have addressed power cord defects that can interrupt the device’s function, putting patients at risk.

Why Choose KBD Attorneys as My HeartMate Recall Lawyer in Baltimore, MD?

Decades of Medical Device Litigation

KBD Attorneys has recovered over $100 million in drug injury and product liability cases and has been litigating defective medical device claims since the firm’s founding. The HeartMate case presents unique legal challenges, including potential federal preemption arguments. Because the HeartMate II and HeartMate 3 are Class III devices that received Premarket Approval from the FDA, the manufacturer will likely argue that federal approval shields it from state-law claims. Our attorneys have direct experience involving medical device preemption and are prepared for this fight.

Brian Ketterer has concentrated his career on pharmaceutical and medical device litigation, representing plaintiffs injured by unreasonably dangerous products. He is recognized among the 100 Best Trial Lawyers by the National Trial Lawyers Association and is designated among the Mass Tort Trial Lawyers Top 25. Justin Browne focuses on mass tort and medical device cases and has been selected as a Super Lawyers Rising Star from 2012 through 2018. Robert Price has dedicated his entire legal career to products liability litigation and is a member of the American Association for Justice and the Florida Justice Association.

These cases are legally and medically demanding. KBD Attorneys has the background to handle both dimensions.

No Fee Unless We Win

We handle HeartMate recall cases on a contingency fee basis, which means there are no costs to you at any stage unless we obtain a recovery. We fund the investigation, retain the necessary medical and engineering professionals, and pursue the manufacturer at our own expense. If we do not win, you owe us nothing.

Understanding HeartMate Recall Cases

Damages, Liability, and Compensation for HeartMate Cases

Patients injured by the HeartMate device may seek compensation for the full range of damages, including medical expenses for emergency surgery, hospitalization, rehabilitation, and ongoing care. Lost wages and diminished earning capacity are also recoverable. Noneconomic damages cover the patient’s pain and suffering, emotional distress, and reduced quality of life. In cases where a patient died, surviving family members may pursue wrongful death claims.

Liability in HeartMate cases centers on whether the device was defectively designed and whether the manufacturer adequately disclosed known risks. The rigid elbow and porous DACRON graft design creates a foreseeable risk of biological matter accumulation, blood flow obstruction, and the cascade of injuries described above. The manufacturer’s knowledge of these risks including when it became aware of adverse events, and the timing and adequacy of its recalls, are central issues in the litigation.

Internal company documents, communications with the FDA, clinical trial data, and post-market surveillance reports are all critical evidence. Our attorneys know how to obtain these records through discovery and how to use them to demonstrate that the manufacturer knew or should have known about the device’s risks before patients were harmed.

Federal preemption is the primary defense anticipated in these cases. The argument is that because the FDA approved the HeartMate as a Class III PMA device, state-law tort claims are barred. This defense has been raised in other medical device litigation and does not always succeed. Courts have recognized exceptions when the manufacturer violated federal requirements or when claims are based on state duties that parallel federal standards. Our attorneys have litigated device cases at this level before and understand the legal framework for overcoming preemption arguments.

What Are Important Aspects of a HeartMate Case?

Several factors play a significant role in the strength of a HeartMate recall claim, and gathering this information early gives your attorney the foundation needed to build the case.

• Medical records documenting the device implantation, adverse events, and any revision surgery
• Recall notices received from the manufacturer or the implanting hospital
• The specific model and serial number of the implanted device
• Whether the FDA’s inspection findings or adverse event reports support the claim
• The timeline of symptoms and whether they correlate with known device failure patterns

These cases benefit from early attorney involvement, as evidence from the manufacturer and the implanting hospital is critical.

What Is the HeartMate Recall Case Timeline?

Medical device litigation typically moves through multi-district litigation proceedings.

• Intake includes gathering medical records, device identification, and adverse event documentation
• The legal team evaluates whether the case meets the criteria for inclusion in any pending litigation
• Discovery in device cases involves obtaining internal manufacturer documents, testing data, and communications with the FDA
• Bellwether trials may be selected to establish case value and test legal theories
• Settlement discussions may occur at the individual or aggregate level

These cases often take two to four years to resolve. The multi-district litigation process has its own procedural timeline.

What Should You Bring to Your HeartMate Recall Consultation?

Having the following documentation available before your first meeting allows our attorneys to evaluate your claim more thoroughly and provide a more accurate assessment of your legal options.

• Medical records showing when the HeartMate was implanted and by whom
• Records of any adverse events, hospitalizations, or surgeries related to the device
• Any recall notices or communications from the manufacturer
• The device identification card provided at the time of implantation

We will review your case during a free consultation and explain whether you have a viable claim.

What Are Important Maryland Legal Resources for HeartMate Recall Cases?

Heart device litigation implicates both state and federal law. The following resources provide relevant information.

• The Maryland General Assembly publishes the three-year personal injury statute of limitations under § 5-101
• The FDA MAUDE database contains adverse event reports submitted by patients, providers, and manufacturers
• The CDC heart disease page provides information about heart failure, the condition that the HeartMate is designed to treat
• The Consumer Product Safety Commission tracks consumer product defects, though medical devices fall primarily under FDA jurisdiction

Reach Out to KBD Attorneys to Schedule a Consultation

If you or a loved one was harmed by a HeartMate device, time is important. Evidence from the manufacturer and the hospital is critical, and the statute of limitations applies. KBD Attorneys offers free consultations and charges no fee unless we recover. Contact us to speak with our HeartMate recall lawyers about your case. We are actively accepting these claims.