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

2021年4月15日—DevicesimpactedbytherecallincludeMedtronic'sEvera,Viva,Brava,Claria,Amplia,CompliaandVisiaICDsandCRT-Ds.Thebatteryissueis ...

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.

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

FDA | 合法醫療器材資訊網

2021年4月12日 — 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 ... Read More

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

Medtronic is recalling some of its implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy. April 12, 2021 — Medtronic is ... Read More

Medical Device Recalls | 合法醫療器材資訊網

CRT | 合法醫療器材資訊網

Urgent medical device recall for Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs). 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

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

2021年4月15日 — Devices impacted by the recall include Medtronic's Evera, Viva, Brava, Claria, Amplia, Complia and Visia ICDs and CRT-Ds. The battery issue is ... Read More

Medtronic Cardiac Defibrillators Recalled Due To Plant Problem | 合法醫療器材資訊網

The defects found in the Medtronic pacemaker and defibrillator models were discovered to cause an “out of specification gas mixture inside the device which may ... Read More

Medtronic Recalls Defibrillators Over Manufacturing Defect ... | 合法醫療器材資訊網

2018年2月26日 — A defect in the manufacturing process of certain Medtronic cardiac defibrillators, including implantable models, prompted a US Food and Drug ... Read More

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