Boston Scientific Corporation: EMBLEM MRI S-ICD Pulse Generator Model A219;
Recall reason: 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.. Recalled by Boston Scientific Corporation. Distribution: Worldwide. Classification (Class II — potential health risk). Affected lots/dates: GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or replacement.
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