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

2021年4月15日—Medtronicfirstinitiatedtherecall,whichincludesatotalof239,171devices,inFebruary2021.Allaffectedhealthcareproviderswerealertedat ...

The FDA has announced that Medtronic is recalling multiple implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to an “unexpected and rapid decrease in battery life.” This is a Class I recall, meaning “use of these devices may cause serious injuries or death.”

There have been 444 complaints about these devices so far, including 18 injuries, but no deaths have been reported.

Devices impacted by the recall include Medtronic’s Evera, Viva, Brava, Claria, Amplia, Complia and Visia ICDs and CRT-Ds. The battery issue is caused by a short circuit, the company has said, and can result in full batter depletion within just one day. Users will note that a “Recommended Replacement Time” warning appears when the issue strikes, alerting them that they need to take action.

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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 details Class I recall of nearly 240 | 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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