Approaching the One-Year Anniversary of Abbott’s HeartMate II and Heartmate 3 Recalls

Abbott makes a medical device called the Heartmate. The FDA approved the Heartmate as a medical device. The Heartmate has different models, the Heartmate II (or Heartmate 2 as some write it) and the Heartmate 3 (which some mistakenly write as Heartmate III).

As we near the one-year anniversary of the FDA’s announced recall of Abbott’s HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS), the spotlight on medical device safety shines brighter than ever. At Ketterer, Browne, and Associates, LLC, we have dedicated significant attention to heart-related devices, including representing individuals impacted by medical device failures. Recently, that includes the:

• Impella heart pump recall,
• RMU recall,
• BioZorb recall, and others.

In our experience having represented thousands of people, recalls don’t always get the word out; many people suffer an injury unaware there’s been a reported problem with the device. Thus, it’s important to share information as we are here in advance of the anniversary. Families have experienced a Heartmate death and need to know there may be help available. As people learn about the Heartmate recall, they may find they have legal rights from a Heartmate injury.

What are the HeartMate II Recall and Heartmate 3 Recall about?

On January 2024, Abbott recalled its Heartmate devices, the Heartmate II (Heartmate 2) and Heartmate 3 (three). The Heartmate recall was due to critical safety concerns. The FDA recall notice is here: https://www.fda.gov/medical-devices/medical-device-recalls/abbottthoratec-corp-recalls-heartmate-ii-and-heartmate-3-left-ventricular-assist-system-lvas-due?utm_medium=email&utm_source=govdelivery#list

Some risks mentioned in the Heartmate recall were outflow graft twisting and pump thrombosis, leading to reduced blood flow, device malfunction, and potentially life-threatening complications. The FDA categorized these recalls as Class I—the most serious type—because of the risk of death or severe injury. For further details, view the FDA’s recall database entries for HeartMate II https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206034 and HeartMate 3 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206012.

What are Some Symptoms a Patient May Experience after a Failed Heartmate II or Heartmate 3 device?

When a HeartMate II or HeartMate 3 left ventricular assist device (LVAD) fails, it may lead to several serious and potentially life-threatening symptoms. The device is no longer adequately supporting heart function. Common symptoms include:

Immediate/Severe Symptoms:

– Sudden shortness of breath or severe difficulty breathing
– Dizziness, lightheadedness, or fainting (syncope)
– Chest pain or pressure
– Rapid, irregular heartbeat
– Extreme fatigue or weakness
– Loss of consciousness

Signs of Heartmate Malfunction:

– Device alarms going off
– Changes in pump sounds or vibrations
– Decreased or no pump flow
– Signs of worsening heart failure
– Swelling in legs, ankles, and feet
– Confusion or altered mental status due to poor perfusion
– Cool, clammy skin, particularly in extremities
– Decreased urine output

This may be a medical emergency requiring immediate attention. Patients with LVAD devices typically have emergency protocols and should:

1. Immediately check their backup battery/power source
2. Contact their VAD coordinator or emergency services
3. Go to the nearest hospital with LVAD expertise
4. Have their emergency contact card/information readily available

We should note that if you’re experiencing any of these symptoms, please seek immediate medical attention; do not rely on this information alone.

Symptoms of HeartMate Device Failure That May Be Related to the Heartmate 3 Recall or Heartmate 2

We provided information above about symptoms and complications you may see from a Heartmate. Patients with a failing HeartMate device may experience:

– Chest pain or discomfort
– Difficulty breathing
– Dizziness or fainting
– Signs of infection, such as fever or redness at the surgical site
– Fatigue or reduced exercise tolerance

These symptoms demand immediate medical attention. The importance of recognizing these warning signs cannot be overstated, as delayed intervention could have catastrophic outcomes. Left untreated, patients may suffer a cardiac injury. These complications may be related to the Heartmate. Patients with a Heartmate II (Heartmate 2) or Heartmate 3 (Heartmate 3) who suffered an injury, or families of patients who died and had a Heartmate may have a legal claim. Let our product liability lawyer investigate. Contact us now at 855-KBA-LAWS (522-5297).

Legal Challenges in Medical Device Litigation

Product liability cases involving medical devices like the HeartMate II and Heartmate 3 face unique legal hurdles, including preemption. Federal preemption shields medical device manufacturers from liability if the device has FDA premarket approval. However, exceptions exist when evidence demonstrates manufacturing defects, mislabeling, or failure to warn of post market risks. Our blog post, [“FDA Recall: HeartMate 3,”](https://kbaattorneys.com/blog/fda-recall-heartmate3/) delves deeper into these legal challenges and strategies to overcome them.

At KBA Attorneys, our extensive experience in working on, supporting, and leading Plaintiffs’ Executive Committees and Plaintiff Steering Committees (PSCs) and trying complex medical device cases equips us to navigate these legal complexities. We have started medical device litigations on our own and single handily resolved them for our clients. Our medical device lawyers have litigated with the biggest and best firms in the country. Our product liability lawyer team is well equipped to help anyone the Heartmate inured and every family who experienced a Heartmate death.

The Impact on Patients and Cardiology

The HeartMate recalls have far-reaching implications for both patients and the broader field of cardiology. As noted by Keck Medicine, these recalls represent a setback in the trust and reliance placed on life-saving devices. Patients may face heightened anxiety, financial strain, and the physical toll of dealing with device failure. Meanwhile, cardiology professionals are grappling with increased scrutiny and the challenges of addressing patients’ fears.

Exploring the Larger Trend in Heart Device Recalls

The HeartMate recalls are not isolated incidents. There have been recalls concerning Abbott’s Impella heart pumps. One is due to risks such as left ventricular perforation. For an in-depth look at this trend, visit our page on the Impella Heart Pump Recall.

Impella Heart Pump Recall – Perforated Left Ventricular Wall

These heart device recalls underscore the systemic challenges in ensuring medical device safety.

How KBA Attorneys Advocates for Patients

At KBA Attorneys, we understand the devastating impact that medical device failures can have on patients and their families. Our attorneys have been at the forefront of product liability litigation, particularly cases involving medical devices. We leverage our expertise to:
– Investigate claims thoroughly
– Collaborate with medical experts
– Challenge preemption defenses
– Secure compensation for medical expenses, pain, and suffering

For the latest updates and insights, visit our blog posts on the latest Abbott HeartMate recall

Latest Abbott HeartMate System Recall and What It Means for Patients

and

More News about the HeartMate II and HeartMate 3 Recalls

Moving Forward

The HeartMate recall highlight the urgent need for adherence to stringent safety standards in medical device manufacturing. As legal advocates, we remain committed to holding manufacturers accountable and fighting for the rights of those affected. For more information or a free consultation, contact KBA Attorneys today.

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**Sources:**
– [FDA Recall: HeartMate II and III](https://www.fda.gov/medical-devices/medical-device-recalls/abbottthoratec-corp-recalls-heartmate-ii-and-heartmate-3-left-ventricular-assist-system-lvas-due?utm_medium=email&utm_source=govdelivery#list)
– [ACC: FDA Update on HeartMate Recalls](https://www.acc.org/Latest-in-Cardiology/Articles/2024/04/17/16/03/fda-update-heartmate-ii-and-heartmate-3-lvas-recalled-due-to-obstruction)
– [Keck Medicine: HeartMate 3 Recall](https://www.keckmedicine.org/physician-hub/is-the-fda-heartmate-3-recall-a-setback-for-cardiology/)