Z-0258-2027

Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750

Name: Z-0258-2027 Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Creator: Boston Scientific Cork, Ltd.
Published: 2026-09-16
License: https://open.fda.gov/license/

Boston Scientific Cork, Ltd. / initiated 2026-09-16 / Open, Classified

FDA source

Recall record

Recall number: Z-0258-2027
Status: Open, Classified
Initiated: 2026-09-16
Posted: 2026-10-22
Recalling firm: Boston Scientific Cork, Ltd.
Product: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Product code: KRA Catheter, Continuous Flush
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 root cause: Process control
Action: On 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 commerce: 432
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.
Product codes and lots: Material Number: M001195750; UDI-DI: 08714729839729; Batch Numbers: 38049562, 38112644, 38112645, 38181975, 38259489, 38273638, 38342770, 38346223, 38399380, 38707974, 39074174, 39074176, 39092273, 40470667, 40476303, 40485786, 40485787, 40493318, 40495100, 40507439, 40512986, 40512987, 40523966, 40524003, 40531398, 40531399;

Product code KRA

K163701Class IIDirexion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation / cleared 2017-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-21, the FDA export date for this dataset. Page last changed 2026-10-27. View this recall on fda.gov (opens on fda.gov)