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.

26–41 of 41

  • ModerateFDA (Devices)·Z-0252-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 860 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/155; Material Number: M001195650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0261-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 926 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0223-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 126 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/105; Material Number: M001195200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 112 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/155; Material Number: M001195510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0262-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 86 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/STRAIGHT/1RO/130; Material Number: M001195910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 39 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/STRAIGHT/1RO/105; Material Number: M001195400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0234-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 486 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/SWAN/1RO/155; Material Number: M001195310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 598 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/155; Material Number: M001195620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0259-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 658 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/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific Cork, Ltd. is recalling 609 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/130; Material Number: M001195710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0244-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 357 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/155; Material Number: M001195450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 1,292 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/155; Material Number: M001195250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0232-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 42 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/105; Material Number: M001195290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 7,945 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

    Product
    Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0226-2027·2026-10-28

    Boston Scientific Recalls Defective Direxion Torqueable Microcatheters

    Boston Scientific is recalling 689 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/105; Material Number: M001195230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2027·2026-10-28

    Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects

    Boston Scientific is recalling 459 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/STRAIGHT/1RO/155; Material Number: M001195220
    Category
    Medical Device
    Distribution
    Distributed nationwide