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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-2106-2025 - Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardio... 2 07/10/2025 FEI # 2124215
Boston Scientific Corporation
Z-2103-2025 - VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103... 2 07/10/2025 FEI # 2124215
Boston Scientific Corporation
Z-2104-2025 - VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only. 2 07/10/2025 FEI # 2124215
Boston Scientific Corporation
Z-2105-2025 - VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various... 2 07/10/2025 FEI # 2124215
Boston Scientific Corporation
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