Medtronic’s Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Recalled Due to Manufacturing Error Preventing Electrical Shock Delivery
Meyers & Flowers is warning pacemaker patients about Medtronic’s Class I recall of its Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators. The cardiac pacemaker device is being recalled due to a manufacturing error which is causing issues with the electrical shock delivery, the key lifesaving function of the device.
Medtronic began alerting doctors of the issues with the product in January. The U.S. Food and Drug Administration issued a notice of the recall on Feb. 26. A Class I recall is the agency’s most serious recall and indicates that the use of this device may lead to serious injury or death.
More than three million people in the US have pacemakers to help them regulate an arrhythmia or abnormal heart rhythm. Pacemakers control irregular heartbeats by using small electrical pulses to adjust the heart to beat faster or slower as needed. Because of the manufacturing error, the device may malfunction and not deliver the critical electrical shock needed to adjust a patient’s heartbeat or revive a patient in cardiac arrest.
At Meyers & Flowers, our attorneys specialize in prosecuting large corporate medical device manufactures such as Medtronic, a global market leader in cardiac pacemakers and one of the largest medical device manufacturers in the world. Our history of success litigating defective medical device corporations has resulted in help for numerous patients.
If you or a family member have been injured by a Medtronic Cardiac Resynchronization Therapy with Defibrillation device or a Medtronic Implantable Cardioverter Defibrillators device, or have one of the pacemaker devices implanted contact our office right away.