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Boston Scientific Corporation Recall: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Comp

Boston Scientific Corporation Recall: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Comp is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD);

Recalling firmBoston Scientific Corporation
ProductEMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Reason for recallThere is potential for fractures which results in the inability to delivery therapy.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionWorldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Recall initiated20201113
Recall numberZ-0879-2021
Categorydevice
StateMN
CountryUnited States

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