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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-0822-2025 - ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
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1
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01/10/2025
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Boston Scientific Corporation
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Z-0823-2025 - PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
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1
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01/10/2025
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Boston Scientific Corporation
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Z-0827-2025 - VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
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1
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01/10/2025
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Boston Scientific Corporation
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Z-0825-2025 - ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
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1
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01/10/2025
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Boston Scientific Corporation
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Z-0826-2025 - VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
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1
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01/10/2025
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Boston Scientific Corporation
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Z-0824-2025 - ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
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1
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01/10/2025
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Boston Scientific Corporation
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