Reported Jul 29, 2026 · Ongoing
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the…
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) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01
- Lot codes and dates
- UDI-DI00191506043131
- Lots
326 of 326 codes
CL12695CL12696CL12699CL12700CL12703CL12808CL12816CL12817CL12823CL12834CL12835CL12836CL12853CL12860CL12882CL12883CL12884CL12891CL12907CL12908CL12909CL12919CL12949CL12950CL12969CL12976CL12979CL12980CL13005CL13010CL13011CL13012CL13018CL13032CL13033CL13034CL13037CL13056CL13057CL13058CL13074CL13075CL13076CL13077CL13097CL13098CL13099CL13100CL13104CL13115CL13116CL13117CL13118CL13119CL13135CL13136CL13137CL13138CL13139CL13156
- Amount recalled
- 508,151 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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