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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-2754-2026 - FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
Z-2757-2026 - FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
Z-2756-2026 - FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
Z-2755-2026 - FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
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