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Boston Scientific Corporation Recall 86902

Description: EMBLEM S-ICD Model A209

Boston Scientific Corporation Recall 86902 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0950-2021
Event ID86902
Event DescriptionEMBLEM S-ICD Model A209
Product TypeDevices
DistributionDistribution throughout United States and worldwide.
Quantity1953 units
Recall ReasonElectrical overstress may lead to device malfunction.
Device Classification20210217
Device Code InfoSerial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 104340, 104341, 104348, 104349, 104351, 104355, 104356, 104357, 104365, 104430, 104440, 104562, 104736, 104778, 104812, 104813, 104816, 104879, 104892, 104905, 104906, 104914, 104915, 104920, 104926, 104931, 104934, 104935, 104938, 104939, 104943, 104946, 104947, 104964, 104967, 104970, 104972, 104988, 104989, 104991, 104995, 104999, 105014, 105016, 105018, 105019, 105020, 105021, 105022, 105023, 105025, 105027, 105039, 105040, 105041, 105046, 105048, 105053, 105054, 105056, 105059, 105063, 105064, 105066, 105070, 105073, 105074, 105078, 105080, 105086, 105089, 105116, 105117, 105130, 105131, 105132, 105143, 105162, 105163, 105164, 105167, 105169, 105179, 105188, 105192, 105200, 105201, 105217, 105218, 105236, 105238, 105239, 105245, 105248, 105272, 105276, 105304, 105309, 105310, 105312, 105319, 105321, 105325, 105328, 105329, 105330, 105332, 105347, 105348, 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Center Classification Date20210205
Recall Initiation Date20201202
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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