Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life Medtronic is recalling the ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease in battery life is caused by a short circuit and will cause some devices to produce a "Recommended Replacement Time" (first warning that the battery is low) earlier than expected. Some devices may progress from "Recommended Replacement Time" to full battery depletion within as little as one day. If the user does not respond to the first warning, the device may stop functioning. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Questions? If you have questions about this recall, contact the Division of Industry and Consumer Education (DICE). |
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