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...

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2021 Medical Device Recalls | 合法醫療器材資訊網

List of Medical Device recalls in 2021. ... Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information ... Read More

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

2021年4月12日 — Reason for Recall. Medtronic is recalling the specified ICDs and CRT-Ds due to an unexpected and rapid decrease in battery life. The decrease ... Read More

Urgent Medical Device Correction | 合法醫療器材資訊網

沒有這個頁面的資訊。 Read More

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

April 12, 2021 — Medtronic is recalling some of its implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT-D) devices because ... 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

FDA details Class I recall of nearly 240 | 合法醫療器材資訊網

2021年4月15日 — Medtronic first initiated the recall, which includes a total of 239,171 devices, in February 2021. All affected healthcare providers were alerted at ... Read More

Medical Device Recalls | 合法醫療器材資訊網

Implantable Cardioverter Defibrillator (2021-02 | 合法醫療器材資訊網

2021年2月19日 — Medtronic has identified that a small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened ... Read More

相關資訊整理

FDA | 合法醫療器材資訊網

2021 Medical Device Recalls | 合法醫療器材資訊網

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

Urgent Medical Device Correction | 合法醫療器材資訊網

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

FDA | 合法醫療器材資訊網

FDA details Class I recall of nearly 240 | 合法醫療器材資訊網

Medical Device Recalls | 合法醫療器材資訊網

Implantable Cardioverter Defibrillator (2021-02 | 合法醫療器材資訊網

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