Boston Scientific Corporation — FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Nu
⚠️ Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2026
Global Distribution. US Nationwide.
What's affected?
- Product
- 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
- Lot code
- CL12695
Additional details
UDI-DI: 00191506043131; Lots: CL12695, CL12696, CL12699, CL12700, CL12703, CL12808, CL12816, CL12817, CL12823, CL12834, CL12835, CL12836, CL12853, CL12860, CL12882, CL12883, CL12884, CL12891, CL12907, CL12908, CL12909, CL12919, CL12949, CL12950, CL12969, CL12976, CL12979, CL12980, CL13005, CL13010, CL13011, CL13012, CL13018, CL13032, CL13033, CL13034, CL13037, CL13056, CL13057, CL13058, CL13074, CL13075, CL13076, CL13077, CL13097, CL13098, CL13099, CL13100, CL13104, CL13115, CL13116, CL13117, CL13118, CL13119, CL13135, CL13136, CL13137, CL13138, CL13139, CL13156, CL13157, CL13191, CL13192, CL13193, CL13194, CL13197, CL13208, CL13209, CL13210, CL13215, CL13216, CL13217, CL13224, CL13229, CL13230, CL13257, CL13258, CL13288, CL13289, CL13337, CL13338, CL13365, CL13366, CL13384, CL13398, CL13399, CL13419, CL13420, CL13423, CL13467, CL13469, CL13470, CL13471, CL13472, CL13517, CL13525, CL13526, CL13527, CL13528, CL13535, CL13536, CL13541, CL13550, CL13551, CL13552, CL13553, CL13555, CL13564, CL13565, CL13566, CL13571, CL13574, CL13575, CL13576, CL13598, CL13599, CL13616, CL13637, CL13642, CL13643, CL13644, CL13665, CL13666, CL13667, CL13668, CL13704, CL13705, CL13706, CL13715, CL13716, CL13721, CL13734, CL13735, CL13736, CL13761, CL13762, CL13763, CL13798, CL13799, CL13800, CL13822, CL13825, CL13826, CL13835, CL13836, CL13837, CL13858, CL13859, CL13860, CL13912, CL13913, CL13914, CL13927, CL13928, CL13929, CL13942, CL13944, CL13945, CL13974, CL13975, CL13981, CL13990, CL13991, CL13992, CL14027, CL14028, CL14029, CL14040, CL14041, CL14042, CL14053, CL14054, CL14055, CL14079, CL14080, CL14081, CL14122, CL14123, CL14124, CL14139, CL14140, CL14141, CL14169, CL14172, CL14173, CL14174, CL14188, CL14189, CL14190, CL14227, CL14228, CL14229, CL14250, CL14251, CL14252, CL14288, CL14289, CL14290, CL14347, CL14348, CL14377, CL14378, CL14398, CL14399, CL14400, CL14440, CL14441, CL14442, CL14489, CL14490, CL14492, CL14493, CL14496, CL14502, CL14505, CL14506, CL14520, CL14583, CL14584, CL14585, CL14634, CL14636, CL14637, CL14671, CL14672, CL14673, CL14674, CL14698, CL14699, CL14700, CL14712, CL14713, CL14714, CL14715, CL14751, CL14752, CL14753, CL14771, CL14772, CL14773, CL14774, CL14815, CL14816, CL14817, CL14818, CL14856, CL14857, CL14858, CL14859, CL14872, CL14873, CL14874, CL14930, CL14931, CL14932, CL14936, CL14937, CL14938, CL14970, CL14971, CL14972, CL15006, CL15007, CL15010, CL15011, CL15068, CL15069, CL15070, CL15080, CL15089, CL15110, CL15130, CL15131, CL15132, CL15194, CL15195, CL15196, CL15241, CL15242, CL15243, CL15273, CL15274, CL15275, CL15276, CL15319, CL15320, CL15321, CL15322, CL15359, CL15360, CL15361, CL15362, CL15398, CL15399, CL15400, CL15401, CL15428, CL15429, CL15430, CL15431, CL15451, CL15475, CL15476, CL15477, CL15491, CL15492, CL15493, CL15494, CL15525, CL15540, CL15541, CL15548, CL15549, CL15570, CL15583, CL15584, CL15599, CL15603, CL15617, CL15641, CL15642, CL15718, CL15756, CL15769, CL15770, CL15777
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 508,151 units.
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