FDA | 合法醫療器材資訊網

2021年4月12日—MedtronicissuedanurgentmedicaldevicecorrectionlettertohealthcareprovidersonFebruary3,2021,advisingthemtocontinuenormal ...

The devices may have battery issues that can lead to full battery depletion within a single day.

The US Food and Drug Administration is warning physicians about a recall initiated in February for several implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by Medtronic: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia. Today, the FDA categorized this action as a Class I recall, its most serious type, meaning that use could cause serious injuries or death.

The devices are being recalled due to an unexpected and rapid decrease in battery life caused by a short circuit. This defect may case some devices to prematurely produce a “Recommended Replacement Time” (RRT) low-battery warning as well proceed to full battery depletion within as little as 1 day.

“If the user does not respond to the first warning, the devi...

Medtronic Recalls Evera, Viva, Brava, Claria | 合法醫療器材資訊網

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When Medtronic determines that a recall is necessary, we communicate with ... listed on any U.S. Government list of prohibited or restricted parties. Read More

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2021年4月12日 — Medtronic is recalling some of its implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy. Read More

FDA | 合法醫療器材資訊網

2021年4月12日 — Medtronic issued an urgent medical device correction letter to healthcare providers on February 3, 2021, advising them to continue normal ... Read More

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2021年4月14日 — Medtronic is recalling seven of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to ... Read More

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