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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2015-2021 - ADVANTIO DR EL (pacemaker), Model Numbers:
a) J064
b) J067
c) K064 (added 7/15/2021)
d) K084 (added 7/15/2021)
e) K087 (added 7/15/2021)
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1
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07/13/2021
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Boston Scientific Corporation
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Z-2016-2021 - INGENIO DR EL (pacemakers), Model Numbers:
a) J174
b) J177
c) K174 (added 7/15/2021)
d) K184 (added 7/15/2021)
e) K187 (added 7/15/2021)
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1
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07/13/2021
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Boston Scientific Corporation
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Z-2020-2021 - INLIVEN CRT-P, Model Numbers:
a) V284
b) V285
c) W274
d) W275 (added 7/15/2021)
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1
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07/13/2021
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Boston Scientific Corporation
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Z-2018-2021 - INVIVE CRT-P, Model Numbers:
a) V172
b) V173
c) V182
d) V183
e) W172
f) W173
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1
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07/13/2021
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Boston Scientific Corporation
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Z-2019-2021 - INTUA CRT-P, Model Numbers:
a) V272
b) V273
c) W273
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1
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07/13/2021
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Boston Scientific Corporation
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Z-2017-2021 - VITALIO DR EL (pacemaker), Model Numbers:
a) J274
b) J277
c) K274 (added 7/15/2021)
d) K277 (added 7/15/2021)
e) K284 (added 7/15/2021)
f) K287 (added 7/15/2021)
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1
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07/13/2021
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Boston Scientific Corporation
|