The Recall Desk

Manufacturer

Boston Scientific Cork, Ltd.

41 recalls in our database name Boston Scientific Cork, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
41
Critical
0
Severe
1
Most recent
2026-10-28

Of the 41 recalls from Boston Scientific Cork, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 41

  • SevereFDA (Devices)·Z-0254-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 1,442 Direxion Torqueable Microcatheters worldwide due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0245-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 382 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0224-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 2,547 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0241-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific Cork, Ltd. is recalling 228 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 384 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0251-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 3,145 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0253-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 156 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0243-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 620 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 550 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 358 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 632 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 902 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 3,284 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0231-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 381 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0242-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 76 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 748 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0246-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 45 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 206 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Defects

    Boston Scientific is recalling 378 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0247-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 1,349 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0230-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 1,912 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0258-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 432 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0257-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 1,135 units of Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects

    Boston Scientific is recalling 8,542 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 1,212 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610
    Category
    Medical Device
    Distribution
    Distributed nationwide