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

2021年4月12日—Medtronic'sEvera,Viva,Brava,Claria,Amplia,Compia,andVisiaICDsandCRT-Dscorrectheartarrhythmia.Somedevicesmayhave ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product Medtronic Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Models: Full List of Affected Devices below Serial Numbers: Full List of Affected Devices below Distribution Dates: August 31, 2012 to May 9, 2018 Devices Recalled in the U.S.: 239,171 Date Initiated by Firm: February 3, 2021 Device Use

Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or...

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Evera | 合法醫療器材資訊網

Evera. Implantable Cardioverter Defibrillators (ICDs) for Tachyarrhythmia Management. Evera Dual Chamber ICD. Read More

Evera MRI | 合法醫療器材資訊網

Evera MRI™ ICDs were the first implantable cardioverter defibrillators (ICD) to receive approval for use in the 1.5T and 3T MR-conditional environment. Ensure ... Read More

Evera XT DR and VR ICDs | 合法醫療器材資訊網

Evera XT: Fit for Living. It's contoured. The new PhysioCurve® design provides a 30% reduction* in skin pressure, designed for greater patient comfort.1. Read More

Evera MRI ICD Systems - Indications | 合法醫療器材資訊網

The Evera MRI SureScan defibrillation system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- ... Read More

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

2021年4月12日 — Medtronic's Evera, Viva, Brava, Claria, Amplia, Compia, and Visia ICDs and CRT-Ds correct heart arrhythmia. Some devices may have ... Read More

相關資訊整理

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

Evera | 合法醫療器材資訊網

Evera MRI | 合法醫療器材資訊網

Evera XT DR and VR ICDs | 合法醫療器材資訊網

Evera MRI ICD Systems - Indications | 合法醫療器材資訊網

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

【“美敦力”克萊亞磁振造影植入式心臟整流去顫器】許可證字號:衛部醫器輸字第031822號

【“美敦力”凱諾辛攜帶式呼吸監測器】許可證字號:衛部醫器輸字第032283號

【"美敦力"皮下導線系統】許可證字號:衛署醫器輸字第017414號

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【“美敦力”動力系統器械】許可證字號:衛部醫器輸字第031572號

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【"美敦力" 可植入脊髓內導管】許可證字號:衛署醫器輸字第010443號

【"美敦力" 充水導管及附件】許可證字號:衛署醫器輸壹字第003249號

【“波士頓科技”歐超心臟整律器】許可證字號:衛署醫器輸字第020038號

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【得敷凝膠(未滅菌)】許可證字號:衛署醫器製壹字第003488號

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