Boston Scientific Corporation: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

Hazard

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

Details from the source

Reason for recall: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval. Distribution: Worldwide Quantity: 3,856 units Lot/code info: GTIN: 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002; All EMBLEM S-ICDs enrolled in LATITUDE

UPC codes

00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.