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Medium risk Drugs & MedicationsClass II

Boston Scientific Cork, Ltd. Recall

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

Updated September 16, 2026

Boston Scientific Cork, Ltd. is recalling Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290. Hazard: 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.

Is the Boston Scientific Cork, Ltd. recalled? Yes. This product was recalled by FDA on September 16, 2026. Details below.

What is recalled

Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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.

Brands affected

Boston Scientific Cork, Ltd.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-0232-2027
Classification
Class II
Recalled
September 16, 2026
Read the official notice

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