Reported Oct 28, 2026 · Ongoing
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
Boston Scientific Cork, Ltd.
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 Cork, Ltd. · Boston Scientific Limited, Business And Technology Park, Model Farm Road · Cork
Is this the product you have?
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130
- Material NumberM001195670
- Lot codes and dates
- Material NumberM001195670
- UDI-DI08714729839668
- Batch Numbers
378811003788982937914477379144783791447937943144379813513798135238002448380024493800245038017051380170523802267438022676380733003807330138273216383307403835032738362202383992483839924938434624384346253843968538439687384450133856044838560451386873223881058338810585388277983882779938902297389022983891651338990275389902763899027739092688390926893914352039189848404661364046671740476440404764414049231740492357404934434050748240510454405104554051068340510769405258624053144140531444
- Amount recalled
- 1442
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
This product could cause temporary or reversible health problems — stop using it.
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