FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the cham
Pending LLM rewrite. Source: FDA_DEVICE Z-2757-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
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
- Category
- Medical Device — Devices
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.
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