Reported Oct 28, 2026 · Ongoing
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200
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/SINGLE/021/STRAIGHT/1RO/105
- Material NumberM001195200
- Lot codes and dates
- Material NumberM001195200
- UDI-DI08714729839316
- Batch Numbers
37942457379990533822452738304916384159113868715938707977389165193902941639029419390296403909227840476286404793864052395840525677
- Amount recalled
- 126
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.