EMBLEM MRI S-ICD Model A219
FDA Recall #Z-0951-2021 — Class I — December 2, 2020
Product Description
EMBLEM MRI S-ICD Model A219
Reason for Recall
Electrical overstress may lead to device malfunction.
Recalling Firm
Boston Scientific Corporation — Saint Paul, MN
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
872 units
Distribution
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Code Information
Serial numbers: 100641, 200266, 200291, 200317, 200347, 200348, 200359, 200368, 200369, 200375, 200378, 200431, 200479, 200481, 200631, 200762, 200786, 200787, 200818, 200821, 200822, 200838, 200848, 200854, 200874, 200888, 200889, 200896, 200899, 200905, 200910, 200914, 200919, 200925, 200927, 200965, 200966, 200979, 200986, 200990, 200991, 200992, 200995, 200996, 200997, 201012, 201016, 201021, 201024, 201031, 201036, 201044, 201050, 201103, 201131, 201133, 201135, 201137, 201157, 201172, 201180, 201182, 201188, 201193, 201264, 201333, 201338, 201353, 201424, 201434, 201460, 201464, 201476, 201491, 201498, 201501, 201510, 201512, 201513, 201514, 201515, 201516, 201517, 201521, 201525, 201544, 201545, 201548, 201551, 201555, 201556, 201557, 201558, 201571, 201600, 201651, 201655, 201662, 201709, 201711, 201713, 201714, 201727, 201747, 201748, 202039, 202042, 202062, 202063, 202065, 202083, 202094, 202833, 203238, 203246, 203249, 203285, 203293, 203301, 203302, 203307, 203311, 203330, 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Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.