Boston Scientific Recalls EMBLEM S | 合法醫療器材資訊網

2021年2月10日—BostonScientificRecallsEMBLEMS-ICDSubcutaneousElectrode(Model3501)DuetoRiskofFractures...TheFDAhasidentifiedthisasaClassI ...

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.

EMBLEM S-ICD Subcutaneous Electrode

The EMBLEM S-ICD Subcutaneous Electrode Model 3501 is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator[1] that is intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed. These cardiac devices are implanted under the skin in the upper chest area.