Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart,…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI00191506042516
- Lots
131 of 131 codes
CL12917CL13004CL13017CL13046CL13060CL13080CL13103CL13122CL13123CL13142CL13160CL13196CL13212CL13219CL13231CL13260CL13291CL13340CL13375CL13401CL13422CL13468CL13519CL13573CL13578CL13614CL13646CL13670CL13671CL13708CL13719CL13722CL13732CL13760CL13801CL13802CL13820CL13833CL13856CL13910CL13911CL13925CL13940CL13971CL13972CL13988CL14025CL14039CL14050CL14051CL14076CL14077CL14119CL14120CL14135CL14137CL14171CL14187CL14226CL14249
- Amount recalled
- 193,000 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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