Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Summary
The FDA issued a Class II for Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material N by Boston Scientific Cork, Ltd.. 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 m.
Details
Source
Device Recall
External ID
Z-0249-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
Lot/Code Info: 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;
Quantity Affected: 1212
Reason for Recall
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-16
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Boston Scientific Cork, Ltd. has 41 FDA actions in our database, including 41 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Cork, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Cork, Ltd. have FDA actions?
Boston Scientific Cork, Ltd. has 41 FDA actions in our database, including 41 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0249-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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