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 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

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

沒有這個頁面的資訊。 Read More

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

Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy ... 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

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

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

2021年2月19日 — Medtronic Inc. 710 Medtronic Parkway Minneapolis 55432. Minnesota UNITED STATES. E. EVERA XT DR DIGITAL DUAL CHAMBER ... Read More

FDA classifies Medtronic ICD | 合法醫療器材資訊網

2021年4月12日 — According to a press release from the agency, Medtronic recalled its Evera and Visia brands of ICDs and its Viva, Brava, Claria, Amplia and ... Read More

https:global.medtronic.comxg | 合法醫療器材資訊網

沒有這個頁面的資訊。 Read More

Medtronic has a serious recall of ICDs and CRT | 合法醫療器材資訊網

2021年4月12日 — FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life ... Read More

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