Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
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 · N/A
Is this the product you have?
- Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155
- Material NumberM001195750
- Lot codes and dates
- Material NumberM001195750
- UDI-DI08714729839729
- Batch Numbers
3804956238112644381126453818197538259489382736383834277038346223383993803870797439074174390741763909227340470667404763034048578640485787404933184049510040507439405129864051298740523966405240034053139840531399
- Amount recalled
- 432
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Cork, Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.