FDAFDA recall Z-2756-2026 · Jul 29, 2026

Boston Scientific Corporation: FARADRIVE STEERABLE SHEATH (CLEAR) - US recall

Recall found

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

Reason for recall

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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
Quantity: 508,151 units
Distribution: Global Distribution. US Nationwide.
Recalling firm: Boston Scientific Corporation, Saint Paul, MN
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-06-11

Source: openFDA enforcement record Z-2756-2026 · search recall number Z-2756-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.