Miami Defective Pacemaker Lawyer

How a pacemaker can fail

A pacemaker system depends on its battery, its leads, and its internal software all working together, and a problem in any one of those areas can affect how reliably the heart is paced.

• Premature battery depletion or entry into a restricted safety mode
• Lead fracture, dislodgement, or insulation failure
• Loss of capture (electrical impulse fails to trigger a heartbeat)
• Oversensing or undersensing of the heart's natural rhythm
• Perforation of the heart or surrounding tissue by a lead
• Software errors affecting programming or monitoring
• Migration or displacement of the device itself
• Infection around the device or leads

Pacemaker recalls worth reviewing

Several major pacemaker manufacturers have faced FDA recall action in recent years, and some of these actions involve very large numbers of devices already implanted in patients.

• Boston Scientific's Accolade, Proponent, Essentio, and Altrua 2 pacemaker families, a Class I recall tied to a battery cathode issue that can cause devices to enter a restricted safety mode
• Boston Scientific's Valitude and Visionist CRT-P devices, added to the same Class I recall as the advisory population expanded in 2026
• Abbott's Aveir DR Leadless Pacemaker, recalled after a manufacturing issue was found to cause microcracks in the glass insulator separating the battery from the electronics
• Abbott's Merlin Patient Care System software, recalled after it could fail to properly terminate a pacing capture threshold test
• Medtronic's Sphera DR MRI SureScan pacemakers, recalled over a circuit error that could cause pacing pauses in certain programmed modes

Symptoms that may signal a pacemaker problem

Some of these symptoms come on suddenly, while others build gradually as the device's function declines.

• Lightheadedness, dizziness, or fainting
• Sudden fatigue or weakness
• An unusually slow or irregular heartbeat
• Chest pain or shortness of breath
• Swelling, warmth, or drainage near the implant site
• A device alert or unusual reading during remote monitoring

Compensation available in a pacemaker case

A pacemaker failure can mean urgent medical treatment on top of the cost of a replacement device, and compensation can reflect both.

• Costs of emergency treatment or hospitalization
• Device replacement or revision surgery
• Ongoing cardiac monitoring and future care
• Lost wages and reduced earning capacity
• Pain, suffering, and emotional distress

A wrongful death claim may also be available to families who lose a loved one connected to a pacemaker failure.