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What caused the INGENIO pacemaker recall?

On Behalf of | Feb 28, 2022 | Defective Products |

Irregular heartbeats, heart disease and heart attack impact many people across the world. As our population continues to age, so too does the necessity of pacemaker implantation to support healthy heart function.

Pacemakers are small devices that can be temporarily or permanently implanted. They generate artificial electrical pulses to help pace the heart. These life-saving devices help individuals with arrhythmia, bradycardia or heart disease take part in routine daily activities without the common symptoms of dizziness, shortness of breath or fatigue. The vast majority of pacemaker models operate as intended and your doctor can check it remotely. Sometimes, however, manufacturers rush a product to market too quickly.

Why Boston Scientific recalled the INGENIO family of pacemakers and CRT-Ps

Because of a risk that INGENIO pacemakers may switch to safety mode without cause, there is a Class I recall on these devices. This is the most serious type of recall because this defect can cause significant injury up to and including death.

A pacemaker has a safety mode to protect a patient from a faulty device. However, if the pacemaker switches to safety mode, it can no longer be programmed and will require replacement. If an individual’s heart is reliant on a pacemaker for their heart to maintain a healthy rhythm, this sudden switch to safety mode can create all kinds of problems. They might need a health practitioner to temporarily pace their heart with an external device. If the heart goes too long without racing regulation, the patient may experience a worsening of heart disease and even death.

It is important to know your rights if you or someone you love experiences catastrophic injury or death due to a defective INGENIO pacemaker or CRT-P. The manufacturer is responsible for bringing vigorously tested and safe medical devices to the market, and they should be held accountable when they do not. You may find it helpful to discuss your situation with a professional familiar with these types of claims.