TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
UDI-DI: 00191506042516; Lots: CL12917, CL13004, CL13017, CL13046, CL13060, CL13080, CL13103, CL13122, CL13123, CL13142, CL13160, CL13196, CL13212, CL13219, CL13231, CL13260, CL13291, CL13340, CL13375, CL13401, CL13422, CL13468, CL13519, CL13573, CL13578, CL13614, CL13646, CL13670, CL13671, CL13708, CL13719, CL13722, CL13732, CL13760, CL13801, CL13802, CL13820, CL13833, CL13856, CL13910, CL13911, CL13925, CL13940, CL13971, CL13972, CL13988, CL14025, CL14039, CL14050, CL14051, CL14076, CL14077, CL14119, CL14120, CL14135, CL14137, CL14171, CL14187, CL14226, CL14249, CL14286, CL14287, CL14345, CL14346, CL14375, CL14376, CL14396, CL14397, CL14439, CL14488, CL14500, CL14501, CL14518, CL14519, CL14581, CL14582, CL14633, CL14635, CL14670, CL14697, CL14711, CL14749, CL14750, CL14769, CL14770, CL14813, CL14814, CL14854, CL14855, CL14870, CL14871, CL14928, CL14929, CL14933, CL14934, CL14935, CL14968, CL14969, CL15005, CL15009, CL15067, CL15107, CL15108, CL15109, CL15128, CL15129, CL15191, CL15192, CL15193, CL15239, CL15240, CL15272, CL15318, CL15358, CL15397, CL15427, CL15474, CL15490, CL15539, CL15568, CL15569, CL15597, CL15598, CL15637, CL15638, CL15640, CL15754, CL15755, CL15775, CL15776, CL15808
- Why
- 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.
- Distributed
- Global Distribution. US Nationwide.
- Company
- Boston Scientific Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2757-2026 · retrieved 17 July 2026
Read the official notice