Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with potential for patient harm from air embolism due to hemostatic valve damage, but no reported illnesses or injuries in the source text, fitting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Faradrive Steerable Sheath Clear OUS, a device used to facilitate access to the vasculature and into the chambers of the heart. The recall involves Material Number M004PFCE21M402 and IFU Reference Number 51659727-01, with 193,000 units distributed globally and nationwide in the US.
The recall stems from complaint investigations that identified a subset of air ingress complaints 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.
The risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. Healthcare providers and users of the affected devices should follow the recommended preparation instructions to reduce the risk of valve damage.
Affected lots include CL12917 through CL15808, with UDI-DI 00191506042516. Users should consult their product documentation and contact Boston Scientific for additional information regarding this recall.
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
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 193,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00191506042516
- Lots: CL12917
- CL13004
- CL13017
- CL13046
- CL13060
- CL13080
- CL13103
- CL13122
- CL13123
- CL13142
- CL13160
- CL13196
- CL13212
- CL13219
- CL13231
- CL13260
- CL13291
- CL13340
- CL13375
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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