Recall Z-0233-2027— Boston Scientific Cork, Ltd.

Name: FDA recall Z-0233-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-16

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Cork, Ltd., initiated 2026-09-16. It names one FDA 510(k) clearance: K163701. 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..

Recalling firm: Boston Scientific Cork, Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2026-09-16
Firm location: Cork, Ireland

510(k) clearances named in this recall

1 on FDA's record

K163701 — Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation·cleared 2017-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.