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On January 22, 2018, the US Food and Drug Administration (FDA) issued a Class I recall of a group of cardiac defibrillators. These defective medical devices, manufactured by Medtronic, include their Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs).
The FDA has identified this as a Class I recall, which is the most serious kind. This is because the manufacturing error could prevent the devices from providing the electrical shocks to patients in need, posing a significant risk to their health. The defective devices were manufactured between July 13, 2013 and Aug. 8, 2017. The brand name CRT-Ds that are being recalled include Amplia, Claria, Compia and Viva. The ICD brands are Evera and Visia. Serial numbers are listed on the recall notice on the FDA website.
According to the FDA, the devices have a defect which causes an out of specification (OOS) gas mixture, which can prevent it from delivering electric shocks when needed. OOS refers to testing results that fall outside specified parameters or acceptance criteria.
Heart patients diagnosed with bracycardia (fast heartbeat), tachycardia (slow heartbeat) or heart failure can be prescribed ICD or CRT-D, which are similar to pacemakers. Both ICD and CRT-D are implanted under the skin in the patient’s upper chest. They are then connected to the heart with thin, insulated wires. These devices use electrical shock or pacing technology to regulate heart rhythms and restore a regular heartbeat.
If a defibrillator fails to deliver a shock, or if the timing of the shock is incorrect, a patient in cardiac arrest or having a slow heartbeat could experience a serious injury and/or death.
Medtronic, which is based in Minneapolis, alerted customers in January that an internal defect in the devices could prevent the electrical shock from being delivered in time to prevent a cardiac incident. They recalled nine CRT-D models, 12 ICD models, and sent a recall notice to customers which included an offer for supplemental device warranties. They also contacted physicians about replacing the defective models in patients that had them.
If you or someone close to you has a medical defibrillator manufactured by Medtronic, this recall could affect you. Many cardiac patients with defibrillators may not be aware of who the manufacturer is, or even that they have a defective medical device in their body. Either way, it is never a good idea to put your health at risk.
Health care professionals should also be aware of this issue and be proactive about keeping patients informed.
Call the Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler. We specialize in litigation for defective medical devices; we are the top law firm of our kind in Philadelphia. We can evaluate and handle your case, compassionately and efficiently guiding you through the legal process. Contact us online or call us at 800-369-0899 or 215-569-4000 for a free consultation.