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FARADRIVE Steerable Sheath Clear IDE
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MEDICAL DEVICE RECALLMODERATE

FARADRIVE Steerable Sheath Clear IDE

Boston Scientific recalls FARADRIVE Steerable Sheath Clear IDE over valve damage risk that may cause air embolism.

What to do

If you have a FARADRIVE Steerable Sheath Clear IDE, follow the updated instructions for use: insert the dilator straight through the center of the hemostatic valve and fully advance it into the sheath body to prevent valve damage. Contact Boston Scientific for further guidance.

Recalled
Listed
Updated
Recall No.
Z-2754-2026
Agency
FDA
Firm
Boston Scientific Corporation
Recall ID
99252
Status
ONGOING

Why it was recalled

Boston Scientific is recalling the FARADRIVE Steerable Sheath Clear IDE due to potential hemostatic valve damage that may occur during device preparation. Valve damage can lead to air ingress, potentially causing air embolism and patient harm. The risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062CL12697, CL12698, CL12701, CL12702, CL12824, CL12832, CL12833, CL12861, CL12888, CL12889, CL12912, CL12913, CL12916, CL12918, CL12968, CL12975, CL12977, CL13003, CL13016, CL13019, CL13045, CL13047, CL13059, CL13078, CL13079, CL13101, CL13102, CL13120, CL13121, CL13140, CL13141, CL13158, CL13159, CL13195, CL13211, CL13218, CL13232, CL13233, CL13259, CL13290 (+67 more, see the official notice)Z-2755-202600810087180072
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 51659727-01CL12917, 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 (+91 more, see the official notice)Z-2757-202600191506042516
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 51654495-01CL12695, 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 (+286 more, see the official notice)Z-2756-202600191506043131
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 51636751-01CL12910, CL12978, CL15153Z-2754-202600810087181062

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification