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U.S. Department of Health and Human Services

Class 2 Device Recall Direxion

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 Class 2 Device Recall Direxionsee related information
Date Initiated by FirmSeptember 16, 2026
Date PostedOctober 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0238-2027
Recall Event ID 99906
510(K)NumberK163701 
Product Classification Catheter, continuous flush - Product Code KRA
ProductDirexion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350
Code Information Material Number: M001195350; UDI-DI: 08714729839460; Batch Numbers: 37881102, 37881103, 37943142, 37943143, 37957743, 38439681, 38439682, 38484292, 38527325, 38876320, 38904816, 38904817, 38916510, 38916512, 38990272, 38990273, 38990274, 39029898, 39092695, 39092696;
FEI Number 3002913962
Recalling Firm/
Manufacturer		 Boston Scientific Cork, Ltd.
Boston Scientific Limited, Business And Technology Park, Model Farm Road
Cork Ireland
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn September 16, 2026, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Forward this notice to relevant personnel and any facilities to which the product was transferred. 3. Continue to follow the standard of practice when monitoring patients treated with the product. 4. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 5. Return product to Boston Scientific in accordance with the enclosed instructions.
Quantity in Commerce384
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KRA
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