Device recall

Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670

FDA recall source

Recall number

Z-0254-2027

Event id

99906

Status

Ongoing

FDA classification

Class II

Recalling firm

Boston Scientific Cork, Ltd.

Report date

Oct 28, 2026

Posted

Oct 22, 2026

Initiated

Sep 16, 2026

Center classification date

Oct 22, 2026

Product code

KRA

Device type

Catheter, Continuous Flush

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.

Root cause

Process control

Quantity

1442

Code info

Material Number: M001195670; UDI-DI: 08714729839668; Batch Numbers: 37881100, 37889829, 37914477, 37914478, 37914479, 37943144, 37981351, 37981352, 38002448, 38002449, 38002450, 38017051, 38017052, 38022674, 38022676, 38073300, 38073301, 38273216, 38330740, 38350327, 38362202, 38399248, 38399249, 38434624, 38434625, 38439685, 38439687, 38445013, 38560448, 38560451, 38687322, 38810583, 38810585, 38827798, 38827799, 38902297, 38902298, 38916513, 38990275, 38990276, 38990277, 39092688, 39092689, 39143520, 39189848, 40466136, 40466717, 40476440, 40476441, 40492317, 40492357, 40493443, 40507482, 40510454, 40510455, 40510683, 40510769, 40525862, 40531441, 40531444;

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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K163701

Location

Cork, Ireland