Serious riskFDA DeviceJul 29, 2026Class II

Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage

Boston Scientific identified that certain FARADRIVE Steerable Sheath devices may develop damage to the hemostatic valve if the dilator is not inserted correctly during preparation. Valve damage can allow air to enter the device, which may lead to air embolism—a serious condition where air bubbles reach the bloodstream and heart.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

Review the instructions for use (IFU Reference 51659727-01) before using this device.
When preparing the device, insert the dilator straight through the center of the valve and fully advance it into the sheath body.
If your facility has affected lot numbers, contact Boston Scientific for further guidance.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 4 products — see all of them.

Details

Units affected: 193,000 units
Illnesses reported: None reported
Manufactured in: 4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Classification: Class II
Recall number: Z-2757-2026

In the FDA's words

Description: 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 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. 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 Distribution: Global Distribution. US Nationwide. Affected quantity: 193,000 units
Hazard: 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.

4 products in this recall

Boston Scientific FARADRIVE sheaths recalled for air embolism risk

Boston Scientific found that some air leak complaints were linked to damage to the sheath's hemostatic valve. The damage can happen when the dilator is inserted at the wrong angle during setup, and it may allow air into the device, creating a potential air embolism. This recall covers four FARADRIVE steerable sheath versions, with about 776,000 units affected. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference…
Z-2754-2026 · 400 units
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Numb…
Z-2755-2026 · 74,760 units
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU R…
Z-2756-2026 · 508,151 units
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Re… (this page)
Z-2757-2026 · 193,000 units