Medtronic Recalls its ICDs and CRT | 合法醫療器材資訊網

Medtronicisrecallingsomeofitsimplantablecardioverterdefibrillators(ICD)andcardiacresynchronizationtherapy.April12,2021—Medtronicisrecalling ...

April 12, 2021 — Medtronic is recalling some of its implantable cardioverter defibrillators (ICD)[1] and cardiac resynchronization therapy (CRT-D)[2] devices because of an unexpected and rapid decrease in battery life. The company said this is due to 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, Medtronic said. The likelihood that this issue will occur is constant after approximately three years. after device use.

The U.S. Food and Drug Administration (FDA) issued a a notice April 12 that identified this as a class I recall, the most serious type of recall. Use of these devices may caus...