Direxion Torqueable Microcatheter (M001195240) Recall
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Direxion Torqueable Microcatheter 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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
Which lot codes, UPCs or models are affected?
Material Number: M001195240; UDI-DI: 08714729839354; Batch Numbers: 37818206, 37818207, 37818208, 37818209, 37849382, 37849383, 37849384, 37849385, 37849386, 37849387, 37849388, 37849389, 37914437, 37914438, 37914439, 37914460, 37914461, 37956676, 37956677, 37981347, 38002442, 38022635, 38022636, 38049174, 38112465, 38112466, 38112467, 38112468, 38112469, 38149674, 38149675, 38149676, 38181212, 38181213, 38181214, 38224531, 38224532, 38224533, 38224534, 38259477, 38259478, 38259479, 38290718, 38290719, 38290720, 38290721, 38290722, 38290723, 38350139, 38350320, 38350321, 38350322, 38350323, 38361992, 38361993, 38361994, 38361995, 38361996, 38399233, 38399234, 38399235, 38399236, 38399237, 38399238, 38479516, 38479517, 38506194, 38530448, 38530449, 38560743, 38560744, 38560745, 38560746, 38560747, 38595897, 38595898, 38595899, 38596320, 38596321, 38629336, 38629339, 38629560, 38649503, 38649505, 38687328, 38687329, 38687330, 38687331, 38701165, 38708407, 38708408, 38708411, 38708414, 38708417, 38708418, 38708419, 38745186, 38745187, 38745189, 38769518, 38769519, 38769960, 38769961, 38810595, 38810596, 38810597, 38827709, 38827710, 38827711, 38827712, 38827713, 38827714, 38827715, 38827716, 38827717, 38904801, 38904802, 38904803, 38932705, 38970735, 38970736, 38990278, 38990279, 38990341, 38990343, 38990344, 38990345, 39029646, 39029647, 39029648, 39029649, 39029654, 39074444, 39074445, 39074446, 39074452, 39074453, 39074454, 39074455, 39074456, 39140982, 39140983, 39140984, 39140985, 39140986, 40466475, 40466476, 40466477, 40466585, 40466586, 40466587, 40482558, 40482559, 40482680, 40482681, 40482682, 40488088, 40488089, 40488090, 40488091, 40501038, 40501039, 40501080, 40501081, 40501082, 40501083, 40504691, 40504692, 40507428, 40507429, 40510781, 40510782, 40510783, 40510784, 40510785, 40514124, 40514125, 40521990, 40521991, 40533357, 40533358, 40533359, 40533361, 40533363, 40533365, 40536160, 40536161, 40536162, 40536163, 40536164, 40539613, 40539614, 40539615, 40539616;
- Agency record number
- Z-0227-2027
- Product
- Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
- Recalling firm
- Boston Scientific Cork, Ltd.
- Quantity
- 8542
- 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.
- Recall started
- September 16, 2026
- Report date
- October 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)