Protecting Hearts on Valentine’s Day

When Medical Devices Meant to Help Cause Harm

Valentine’s Day is a reminder of how precious our hearts truly are — not just emotionally, but physically. For many people living with heart disease or heart failure, survival depends on advanced medical technology designed to support or protect the heart’s function.

Devices like heart pumps, implantable cardiac devices, and mechanical circulatory support systems are often described as lifesaving. And for many patients, they are. But when these devices fail, malfunction, or are placed into use without adequate warnings, the consequences can be devastating — physically, emotionally, and financially.

At KBD Attorneys, we’ve written extensively about heart-related medical devices that were meant to save lives but instead placed patients at serious risk. These cases are not about blaming people for their health conditions. They’re about accountability when trust is broken.

Examining Heart Devices Through a Patient Safety Lens

Below are some of the heart-related medical devices that when defective, can cause serious harm. We acknowledge the real experiences of patients whose trust in these products deserved better.

Left Ventricular Assist Devices (LVADs)

LVADs are mechanical heart pumps used to support patients with advanced heart failure, sometimes as a bridge to transplant and sometimes as long-term therapy. While these devices can be critical for survival, certain LVADs have been linked to severe complications, including blood clots, strokes, internal bleeding, pump thrombosis, and device failure. Many patients and families were never fully warned about the frequency or severity of these risks before implantation.

The HeartMate System Monitor was recalled after reports that the screen could freeze, distort, or display incorrect information, making it difficult for clinicians to properly monitor and manage the device. These malfunctions could lead to unintended changes to pump settings or interruptions in blood flow, posing serious risks to patients relying on the system for cardiac support. Read more on HeartMate related recalls.

• HeartMate System Monitor Recall – Covers the FDA correction of the HeartMate LVAS system monitor due to screen issues that could affect device management in patients with LVADs.

• Latest Abbott HeartMate Recall the Most Serious Yet – Discusses the FDA’s Class I recall of the HeartMate Mobile Power Unit, part of the HeartMate II and HeartMate 3 LVAD systems, for power failure risks.

• More News about the HeartMate II and HeartMate 3 Recalls – Provides details and background on the HeartMate II and HeartMate 3 LVAS recalls, including outflow graft issues and adverse outcomes.

• Latest Abbott HeartMate System Recall and What It Means for Patients – Offers a broader overview of the HeartMate recall and implications for patients relying on HeartMate LVAD systems.

• HeartMate II Recall and HeartMate 3 Recall – HeartMate Injury and HeartMate Death – Summarizes the recalls of HeartMate II and HeartMate 3 LVAD devices, symptoms of failure, and legal context.

Catheter-Based Heart Pumps (Including Emergency Heart Support Devices)

Temporary heart pumps used during high-risk cardiac procedures are often deployed in moments of crisis, when patients are most vulnerable. Some of these devices have been associated with vascular injuries, bleeding, limb ischemia, and fatal complications. When problems arise during emergency use, families are often left searching for answers about whether the device, the procedure, or inadequate warnings played a role.

• FDA Issues Early Warning on Abiomed Blood Pump Controller Malfunction Linked to Patient Deaths – Discusses an FDA alert about controller malfunctions for Abiomed Impella blood pump systems used for circulatory support in critically ill patients, including detection failures that can interrupt device function and pose serious risks.

• Impella RP Recall – Covers the FDA recall involving certain Impella heart pumps (e.g., Impella RP with SmartAssist) with updated instructions due to risks related to device interaction and potential pump stoppage.

• FDA Issues Early Alert on Automated Impella Controller Fixation Issue – Reports an FDA early alert about fixation issues with the Automated Impella Controller, which can interrupt purge pressure and hemodynamic support for these catheter‑based pumps.

Implanted Cardiac Devices and Leads

Pacemakers, defibrillators, and their leads are designed to regulate or protect heart rhythm, but defects in these systems can lead to serious harm. Device fractures, insulation failures, electrical malfunctions, and premature battery depletion have all been the subject of litigation and recalls. For patients, this can mean additional surgeries, infections, emotional trauma, or sudden cardiac events — outcomes no one anticipates when trusting a device placed inside their body.

• Boston Scientific Endotak Reliance Defibrillation Lead Recall– This post covers a serious recall of defibrillator leads — the wires implanted in patients’ hearts that deliver life‑saving shocks — after reports of 386 serious injuries and 16 deaths linked to lead calcification, which can interfere with proper shock delivery.
• Boston Scientific Accolade Pacemaker Recall- This post discusses the recall of multiple Boston Scientific pacemaker models (including Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude) due to a battery defect that can cause devices to enter “Safety Mode,” severely limiting their ability to regulate heart rhythm. The recall affected about 203,000 devices and has been associated with injuries and deaths.
• Boston Scientific Accolade Pacemaker Software Update– A follow‑up to the pacemaker recall, this post details a software update released to detect battery issues sooner and prevent some of the dangerous Safety Mode events, though the update itself has limitations and unintended telemetry issues.

When Heart Devices Fail, It’s Not the Patient’s Fault

Patients trust that medical devices have been properly designed, thoroughly tested, and honestly represented. When manufacturers, hospitals, or regulators fall short, the burden should not fall on the people whose hearts were already struggling.

Needing a heart device is not a weakness. Experiencing complications is not a personal failure. And asking questions or seeking legal help is not disloyal to medicine — it’s an act of self-advocacy.

A Valentine’s Day Message of Care and Accountability

This Valentine’s Day, protecting hearts means more than flowers and cards. It means standing up for patients who relied on medical technology and were harmed instead. It means recognizing that love looks like accountability, transparency, and safer care for the future.

At KBD Attorneys, we believe every heart deserves protection — especially those that have already been through too much. If medical devices fail to protect the people they’re meant to help, accountability is one way we work toward healing.