Boston Scientific Cork, Ltd. recalls Direxion Torqueable Microcatheter

Recalling company

Boston Scientific Cork, Ltd.

Product

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 16, 2026

Reported

Oct 28, 2026

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.

Status

Ongoing

Quantity

3284

Lot / codes

Material Number: M001195300; UDI-DI: 08714729839415; Batch Numbers: 37818213, 37818214, 37818215, 37818216, 37881115, 37886786, 37886787, 37886788, 37914463, 37914464, 37914465, 37943140, 37956679, 37957740, 37977611, 38002444, 38002445, 38085044, 38089225, 38092404, 38092405, 38092406, 38112470, 38112471, 38112472, 38149820, 38181217, 38191752, 38220950, 38330637, 38330638, 38415914, 38415915, 38444073, 38444074, 38484290, 38527320, 38527321, 38560452, 38573062, 38573063, 38585014, 38596980, 38596981, 38629571, 38629572, 38769972, 38769973, 38827700, 38827701, 38827702, 38827703, 38827704, 38827705, 38904809, 38904810, 38916514, 38916515, 38937265, 38990849, 38990852, 38990856, 38990857, 39029815, 39143228, 39143230, 40466130, 40466131, 40466631, 40471499, 40471940, 40476290, 40476291, 40476292, 40479473, 40479474, 40479716, 40479717, 40492475, 40493319, 40493333, 40493440, 40497672, 40499680, 40499681, 40505968, 40505969, 40512591, 40512592, 40512593, 40513026, 40513027, 40521923, 40521924, 40525798, 40525799, 40525860, 40531461, 40531462, 40533302, 40535971, 40535972;

Company location

Cork

Recall type

Voluntary: Firm initiated

Recall number

Z-0233-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0233-2027 in the FDA Enforcement Report. Also see FDA recall press releases.