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Boston Scientific Corporation Recall 87014

Description: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Boston Scientific Corporation Recall 87014 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0879-2021
Event ID87014
Event DescriptionEMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Product TypeDevices
DistributionWorldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Quantity47000 units
Recall ReasonThere is potential for fractures which results in the inability to delivery therapy.
Device Classification20210127
Device Code InfoAll serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
Center Classification Date20210119
Recall Initiation Date20201113
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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