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.