Direxion Torqueable Microcatheter recall (Boston Scientific Cork, Ltd.)
Medical deviceClass IIOngoing
Summary: Boston Scientific Cork, Ltd. is recalling Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610. Reason: 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.
What is being recalled
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom. (states named: Puerto Rico)
How to tell if yours is affected
Material Number: M001195610; UDI-DI: 08714729839606; Batch Numbers: 37775581, 37914469, 37914471, 38112478, 38149824, 38149825, 38181969, 38290725, 38342768, 38342769, 38647607, 38647608, 38647615, 38647616, 38649502, 38687333, 38687334, 38708446, 39029659, 40466126, 40466127, 40466473, 40476395, 40485647, 40485732, 40501047, 40504656, 40504657, 40508315, 40512996, 40512997, 40519832, 40519833;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0249-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 16, 2026 |
| Reported | October 28, 2026 |
| Company | Boston Scientific Cork, Ltd. |
| Company location | Cork, Ireland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1212 |
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